MAUDE Adverse Event Report: CONMED UTICA STEALTH 32 LHOOK LAP ELEC PKG; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number 60-5274-132

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/11/2023

Event Type  malfunction  

Manufacturer Narrative

The reported device is being returned to conmed for evaluation.A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation.We will continue to monitor for trends through the complaint system to assure patient safety.H3 other text : device not yet received.

Event Description

The customer reported that the device, 60-5274-132, stealth 32 lhook lap elec pkg, was being used during a laparoscopic partial liver resection procedure on (b)(6) 2023 when it was reported, ¿it was reported that the l-hook electrode was detached and fell into the surgical field during the surgery.The electrode was retrieved and there was no residue inside the body.¿.The fragmentation was removed from the patient using grasping forceps.There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was reported as being completed with only a few seconds of delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

Manufacturer Narrative

Received one 60-5274-132 in original opened package.Lot number was verified.Performed a visual inspection, the complaint was confirmed.The electrode was not attached to device.The electrode was not returned with the device.The root cause cannot be determined, however, based upon the evaluation and the photos, the likely cause may be due to excessive force being used during removal of eschar from the tip.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 was found to have met all specifications prior to shipment.This is the only complaint for this lot number and failure mode within the past two years.A two-year review of complaint history revealed there has been a total of 22 complaints, regarding 23 devices, for this device family and failure mode.During this same time frame 252,395 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 (b)(4).Per the instructions for use, the user is advised the following: examine this device prior to use for damage.Do not use if damage is found.The ifu also advises the user that should eschar adherence occur on the 60-5272 series, the electrode tips can be cleaned with an electrosurgical scratch pad.On the 60-5274 series, with eschar-resistant coating, any adhering can be easily wiped away with a sterile, moistened sponge.We will continue to monitor for trends through the complaint system to assure patient safety.

Event Description

The customer reported that the device, 60-5274-132, stealth 32 lhook lap elec pkg, was being used during a laparoscopic partial liver resection procedure on (b)(6) 2023 when it was reported, ¿it was reported that the l-hook electrode was detached and fell into the surgical field during the surgery.The electrode was retrieved and there was no residue inside the body.¿.The fragmentation was removed from the patient using grasping forceps.There was no report of injury, medical intervention, or hospitalization for the patient.The procedure was reported as being completed with only a few seconds of delay.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.

• Brand Name: STEALTH 32 LHOOK LAP ELEC PKG
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer (Section G): CONMED UTICA; 525 french rd; utica NY 13502
• Manufacturer Contact: john berga ; 11311 concept blvd; largo, FL 33773 ; 7273995358
• MDR Report Key: 18010154
• MDR Text Key: 326588902
• Report Number: 1320894-2023-00235
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 30653405010733
• UDI-Public: (01)30653405010733(17)280506(10)202305081
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K952204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2023

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 Catalogue Number: 60-5274-132
• Device Lot Number: 202305081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/11/2023
• Initial Date FDA Received: 10/26/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2023
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1
• Patient Ethnicity: Non Hispanic