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)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
As reported, one of the jaws on the cutting forceps broke inside the patient.The jaw has been recovered.The issue occurred during a hysterectomy under coelio procedure that caused a fifteen-minute extension.The procedure was completed with a similar device.There were no reports of further patient harm.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The device was returned to olympus for inspection and the reported failure was confirmed due to the jaw being broken inside the shaft.The detached jaw was not returned to olympus.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the most probable cause of the complaint is traced to manufacturing.The issue is being further investigated.The jaw break near the weld between the jaw legs and tip of the jaw.It was discovered that the failing jaw lot had shallower bottom weld penetration, and the weld spanned over a larger area of the feature length compared to the weld of a conforming device.Olympus will continue to monitor field performance for this device.
Event or Problem Description
As reported, one of the jaws on the cutting forceps broke inside the patient.The jaw has been recovered.The issue occurred during a hysterectomy under coelio procedure that caused a fifteen-minute extension.The procedure was completed with a similar device.There were no reports of further patient harm.

• 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: 19713364
• Report Number: 3011050570-2024-10223
• Device Sequence Number: 12890181
• Product Code: GEI
• UDI-Device Identifier: 00821925035867
• UDI-Public: 00821925035867
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K142759
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2024

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: FR373912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/04/2024
• Supplement Date Received by Manufacturer: 09/02/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-1167-2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown