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

Catalog Number	60-5274-132
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The sales representative reported on behalf of the customer that the 60-5274-132, stealth 32 lhook lap elec pkg, was being used during a lap chole procedure on (b)(6) 2023 when it was reported, ¿the laparoscopic l hook broke off during the procedure.¿.There was no report of injury, medical intervention, or hospitalization for the user or patient.The procedure was completed as planned with a few minutes delay.Further assessment questioning found that the component fell into the abdominal cavity of the patient and was retrieved using lap graspers.The patient was discharged as normal.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional 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.Device not yet received.
Event or Problem Description
The sales representative reported on behalf of the customer that the 60-5274-132, stealth 32 lhook lap elec pkg, was being used during a lap chole procedure on (b)(6) 2023 when it was reported, ¿the laparoscopic l hook broke off during the procedure.¿.There was no report of injury, medical intervention, or hospitalization for the user or patient.The procedure was completed as planned with a few minutes delay.Further assessment questioning found that the component fell into the abdominal cavity of the patient and was retrieved using lap graspers.The patient was discharged as normal.This report is being raised due to the reported malfunction with potential for injury upon reoccurrence.
Additional Manufacturer Narrative
Received one 60-5274-132 in opened original packaging.Lot number was verified.Performed a visual inspection, the black insulation on the electrode is frayed and coming off the electrode.The electrode was returned disassembled from the device.There is evidence of soldering on the electrode.A likely cause for this issue is the application of excessive force during use.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.(b)(4).Per the instructions for use, the user is advised to avoid potential damage to trocar seals and to the electrosurgical tip, always slide the tip shield in the covered and locked position during insertion into the trocar cannula.During trocar insertion, always have the electrode tip covered to avoid potential damage to trocar seals and the electrode tip.A determination for further investigation has been initiated.We will continue to monitor for trends through the complaint system to assure patient safety.

• Brand Name: STEALTH 32 LHOOK LAP ELEC PKG
• Common Device Name: 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: 17324541
• Report Number: 1320894-2023-00139
• Device Sequence Number: 5487408
• Product Code: GEI
• UDI-Device Identifier: 30653405010733
• UDI-Public: (01)30653405010733(17)280429(10)202305011
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K952204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 60-5274-132
• Device Lot Number: 202305011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic