MAUDE Adverse Event Report: CONMED CORPORATION STEALTH 32 LHOOK LAP ELECTRODE 5MM X 32CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 60-5274-132

Device Problems Loss of or Failure to Bond (1068); Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 12/27/2019

Event Type  malfunction  

Manufacturer Narrative

To date, although multiple attempts have been made to gather additional information, no information has been provided.At time of filing, although expected, the reported device has not been returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer in (b)(6) reported issues with the stealth 32 lhook lap elec pkg, item # 60-5274-132, lot 201811201, that occurred (b)(6) 2019 during a laparoscopic cholecystectomy procedure on a (b)(6) year old with initials (b)(6).The information indicates that "the hook was covered with protective plastic, so it didn't work.The sheath slipped.It is indicated the issue occurred during a procedure, although there is no information about the procedure outcome or patient impact.To date, although multiple attempts have been made to gather additional information, no information has been provided.If additional information is provided, reportability of this incident will be reassessed.This report is being raised on the basis of previous us fda mdr reporting of similar sheath slipping malfunction (leading to the sheath falling off) with potential for injury upon reoccurrence.

Manufacturer Narrative

B5 additional information was received with clarification of issue.H10: despite numerous attempts over the past month to obtain the device for return to conmed for evaluation, the device has not been located or returned to conmed by the facility.Should the device in question be returned an evaluation will be performed and a supplemental and final report will be filed.The device is not being returned but photographic evidence has been provided that confirmed the reported problem of hte insulation slipping down on the electrode.The manufacturing documents from the device history record have been reviewed with special attention to the manufacturing and inspection of the product.The product released for distribution were found to have met all specifications prior to shipment and found no abnormalities that would contribute to this issue.A two-year lot history review was conducted and found this is the only complaint for this lot number and failure mode.A two-year review of complaint history revealed there has been a total of (b)(4) complaints, regarding (b)(4) devices, for this device family and failure mode.During this same time frame (b)(4) devices have been manufactured and shipped worldwide.Should all the complaint devices have been found confirmed for this reported failure, the rate of failure would be 0.0002.The instructions for use (ifu) provides the user with information regarding proper care and use of this device.The ifu also advises the user to examine this device prior to use for damage.Do not use if damage is found.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

Additional information received clarified that approximately (b)(4) minutes after the beginning of surgery, during the dissection of the calot triangle, the surgeon realized that the tip of the hook wasn't normal; the sheath had slipped.After (b)(4) minute of use, the insulating sheath slipped down towards the tip of the hook.It did not fall into the patient.The hook was not usable because it was covered by the insulating sheath.They changed the device with another electrode and the procedure was successfully completed.

• Brand Name: STEALTH 32 LHOOK LAP ELECTRODE 5MM X 32CM
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 9633905
• MDR Text Key: 183303141
• Report Number: 1320894-2020-00032
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• PMA/PMN Number: K952204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 03/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2023
• Device Catalogue Number: 60-5274-132
• Device Lot Number: 201811201
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/10/2020
• Initial Date FDA Received: 01/27/2020
• Supplement Dates Manufacturer Received: 03/13/2020
• Supplement Dates FDA Received: 03/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR