MAUDE Adverse Event Report: CONMED UTICA SPATULA ELECTROD W/STEALTH ER 5MM X 32CM (5/CS); ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	60-5274-032
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
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.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
Conmed japan reported on behalf of their customer that the 60-5274-032, spatula electrod w/stealth er 5mm x 32cm (5/cs) was being used during a laparoscopic low anterior resection procedure on (b)(6) 2022, when it was reported, ¿the electrode coating was peeling off while using at the surgery.Although it has not been confirmed that it remains inside the body, it cannot be completely ruled out that there is a possibility of it remaining inside the body¿.The procedure was completed with another 60-5274-032, spatula electrod device.The delay was only for the time it took to prepare the replacement.After further assessment questions it was discovered the piece of the fragmented device was not retrieved.Xray imaging was used to help locate the missing piece, but it was unsuccessful.There are no reports of medical intervention or hospitalization for the patient.This report is being raised on the basis of injury with the potential of fragmentation being left behind.
Additional Manufacturer Narrative
Received one 60-5274-032 in opened original packaging.Lot number was verified.Performed visual inspection, it was not confirmed that there were any missing pieces from the insulation.The insulation is torn and has some wearing.A device history record review found no abnormalities that would contribute to this reported event.A two-year lot history review shows 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 15 reports, regarding 22 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 (b)(4).Per the instructions for use, the user is advised the following: the user is advised to always use the lowest possible setting to achieve the desired electrosurgical effect.This issue will continue to be monitored through the complaint system to assure patient safety.
Event or Problem Description
Conmed japan reported on behalf of their customer that the 60-5274-032, spatula electrod w/stealth er 5mm x 32cm (5/cs) was being used during a laparoscopic low anterior resection procedure on (b)(6) 2022, when it was reported, ¿the electrode coating was peeling off while using at the surgery.Although it has not been confirmed that it remains inside the body, it cannot be completely ruled out that there is a possibility of it remaining inside the body¿.The procedure was completed with another 60-5274-032, spatula electrod device.The delay was only for the time it took to prepare the replacement.After further assessment questions it was discovered the piece of the fragmented device was not retrieved.Xray imaging was used to help locate the missing piece, but it was unsuccessful.There are no reports of medical intervention or hospitalization for the patient.This report is being raised on the basis of injury with the potential of fragmentation being left behind.

• Brand Name: SPATULA ELECTROD W/STEALTH ER 5MM X 32CM (5/CS)
• 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: aubrey nardozzi ; 11311 concept blvd; largo, FL 33773 ; 7273995288
• MDR Report Key: 15917038
• Report Number: 1320894-2022-00237
• Device Sequence Number: 12398202
• Product Code: GEI
• UDI-Device Identifier: 30653405010702
• UDI-Public: (01)30653405010702(17)270213(10)202202141
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K952204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 60-5274-032
• Device Catalogue Number: 60-5274-032
• Device Lot Number: 202202141
• 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: 11/18/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 01/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Patient Ethnicity: Non Hispanic