MAUDE Adverse Event Report: GYRUS ACMI, INC. PK CUTTING FORCEPS, 5MM, 33CM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	PK-CF0533
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device was returned and evaluated.During inspection, one of the two jaw was broken.The broken piece of the jaw was not returned.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Event or Problem Description
The customer reported to olympus that during a gynecological surgery, when using the forceps to coagulate and cut, one of the blades of the jaw was broken and was retrieved from the patient.The procedure was completed with a similar device by laparoscopic intervention.Customer reported the same issue happened in different procedure.The physician had the impression that the devices are now softer than before.There were no reports of patient or user harm associated with this event.Patient identifiers: (b)(6) - 1 of 2 procedures.(b)(6) - 2 of 2 procedures.This report is for (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found there was no indication that manufacturing procedures could have caused or contributed to the reported issue.It has been about 1 year since the subject device was manufactured.Based on the results of the investigation, the issue (broken jaw) was found to be linked to a specific jaw lot.A capa (capa-201438) was opened, and a stop shipment was initiated due to the investigation findings.Olympus will continue to monitor field performance for this device.

• Brand Name: PK CUTTING FORCEPS, 5MM, 33CM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17410408
• Report Number: 3011050570-2023-00098
• Device Sequence Number: 13018142
• Product Code: GEI
• UDI-Device Identifier: 00821925035867
• UDI-Public: 00821925035867
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K142759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: PK-CF0533
• Device Lot Number: FR279625
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 11/30/2023
• Initial Report FDA Received Date: 07/27/2023
• Supplement Report FDA Received Date: 12/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ESG-400 (B007548)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown