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

Model Number	PK-CF0533
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A user facility reported to olympus that during a therapeutic laparoscopic hysterectomy, one branch of the pk cutting forceps, 5mm, 33cm fell out of the shaft and into the patient.The device had to be removed laparoscopically with a france clamp.This took an additional 5 minutes while a new device was installed.It was also stated that the device had no abnormalities upon initial inspection and worked until almost the end of the procedure.The procedure was successfully completed with a new device.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the findings are as follows: the jaw was confirmed to be broken off; however, the jaw piece was not returned to examine.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 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.This supplemental report includes an update to h3.A correction has been made to h8 to provide information that was inadvertently not included in the initial medwatch.Also, information has been added to h4.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide a correction to h9."fy24-osta-14" was inadvertently submitted on the previous submission; however, there is no h9 entry at this time and the field should remain blank.

• 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: 17099631
• Report Number: 3011050570-2023-00062
• Device Sequence Number: 16618090
• Product Code: GEI
• UDI-Device Identifier: 00821925035867
• UDI-Public: 00821925035867
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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: 05/24/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2023
• Supplement Date Received by Manufacturer: 11/30/2023; 12/05/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 12/04/2023; 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FY24-OSTA-14
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ESG-400 - UNK LOT/SN; OTV-S300 - UNK LOT/SN; UHI-4 - UNK LOT/SN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female