MAUDE Adverse Event Report: ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. SEMKIN BIPOLAR FORCEPS W/STOPS STR. 14CM, TIP 0.7MM DIA.

Catalog Number	121040BP
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the healthcare facility, a second-degree burn to chin was noted during a rhytidectomy while using the bipolar forceps.
Additional Manufacturer Narrative
The bipolar forceps was not returned for evaluation after three good faith effort (gfe) attempts were made requesting the device's return as well as additional information regarding use of device.Lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history records (dhr) could not be reviewed.It has been determined that the most recent purchases of this device by the reporting healthcare facility occurred in april and june of 2018.Therefore, the device was manufactured over seven years ago.No complaints for bipolar forceps 121040bp are on record.It is not known what accessory cord or generator setting were used with the forceps during the procedure.It has not been possible to confirm this alleged malfunction due to insufficient information.If additional relevant information becomes available in the future, the complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.

• Brand Name: SEMKIN BIPOLAR FORCEPS W/STOPS STR. 14CM, TIP 0.7MM DIA.
• Common Device Name: BIPOLAR FORCEPS
• Manufacturer (Section D): ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.; 300 shames dr.; westbury NY 11590
• Manufacturer (Section G): ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP.; 300 shames dr.; westbury NY 11590
• Manufacturer Contact: marie bonazinga ; 300 shames dr.; westbury, NY 11590 ; 5163332570
• MDR Report Key: 22103343
• Report Number: 2434839-2025-00001
• Device Sequence Number: 12543414
• Product Code: GEI
• UDI-Device Identifier: 00841645100546
• UDI-Public: 841645100546
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K811820
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 05/29/2025

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
• Device Catalogue Number: 121040BP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2025
• Initial Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Race: White