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Terminated

Reusable laparoscopic instruments are packaged as non-sterile. Cleaning and sterilization of devices must occur prior to use. The instruments are intended to be used by qualified physicians to provide access, illumination and visualization of internal structures and for manipulating soft tissue (grasping, cutting, coagulating, dissecting and suturing) in a wide variety of diagnostic and therapeutic laparoscopic/ urologic closed and minimally invasive procedures. It is inserted via a trocar sleeve and is used to prepare, coagulate and cut tissue.

FDA Recall Z-2729-2014 · Posted 2014-09-30

Recalling FirmInstrumed International, Inc.
Recall StatusTerminated
Product CodeGEI
Date Initiated2014-05-30
Date Terminated2017-11-29
Product Quantity15 instruments

Reason for Recall

Additional caution statements have been added to the Instructions For Use for monopolar electrodes. 1) To avoid tissue carbonation, the operation voltage of the HF generator must not exceed 650 peak voltage (Vp) for all monopolar electrodes. and 2) For all monopolar electrodes, the useful life of this product is less than or equal to 50 cycles and less than or equal to 2 years.

Firm Action

Instrumed sent an URGENT: MEDICAL DEVICE CORRECTION letters dated May 30, 2014 to all consignees. The letters advised the consignees of the new warning statements on the product Instructions For Use and an instruction to complete and return the attached Response Request Form to Instrumed International. Consignees were further instructed to extend the recall to the retail level. For questions contact Instrumed Quality Manager at 847-908-6119.

Root Cause

Labeling design

Distribution Pattern

Distribution US Nationwide in the states of: AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K060232TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIESTrokamed GmbH · 2006-07-12

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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