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

Catalog Number 60-5274-132

Device Problems Loss of or Failure to Bond (1068); Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2019

Event Type  Injury  

Manufacturer Narrative

The device in question, used in the procedure, is not available for evaluation by conmed.At time of filing, this reported event is entering the investigation process.A supplemental and final report will be filed following the completion of the complaint investigation.This issue will continue to be monitored through the complaint system to assure patient safety.

Event Description

The customer reported an issue with the 5mm stealth l-hook electrode, item 60-5274-132, lot 201901021 that occurred during use on (b)(6) 2019.It is indicated that the issue occurred during a laparoscopic cholecystectomy which was successfully completed in under 30 minutes as usual.The surgeon involved in the incident is very experienced in using this conmed device and performing the "lap chole".The reporter explained that a grasper is used to hold/pull back the gallbladder while the l-hook is used in the space between the liver and gallbladder.Other instruments are also being used to irrigate and suction as is the normal practice.At the end of the procedure, it was noticed that the insulation had fallen off the l-hook and into the patient's abdomen.It was not noticed prior to this point in the procedure.The large visible fragment was removed , however, they could not be certain all of the insulation fragment was removed.The device used in the procedures were discarded by the facility as is their policy.At this point in time, there is no obvious harm or impact to the patient, who is currently in stable condition.This report is being raised on the basis of injury due to the possibility of the insulation fragment not being totally removed from the patient.

Manufacturer Narrative

The customer complaint regarding the insulation falling off during use is inconclusive.The device will not be returned for evaluation and no photographic evidence has been provided.Therefore, the reported issue cannot be verified.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 lot history review was conducted and found this is the only complaint for this lot number and failure mode.(b)(4).The instructions for use (ifu) provides the user with information regarding proper care and use of this device.Per the ifu, the user is advised to examine the device prior to use for damage.Do not use if damage is found.A determination for further investigation has been initiated.This issue will continue to be monitored through the complaint system to assure patient safety.

• Brand Name: 5MM STEALTH 32CM LHOOK LAP ELECTRODE
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED CORPORATION; 525 french road; utica NY 13502 5994
• MDR Report Key: 9447103
• MDR Text Key: 170706541
• Report Number: 1320894-2019-00413
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2024
• Device Catalogue Number: 60-5274-132
• Device Lot Number: 201901021
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/27/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other