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	03/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A company representative, on behalf of a user facility, reported to olympus two incidents of breakage that occurred while using the pk cutting forceps, 5mm, 33cm.This patient's procedure was a therapeutic hysterectomy.The procedure was delayed 30 minutes; it was stated that there was no deterioration in the patient's health state due to the delay.The part that fell inside of the patient was retrieved using laparoscopic forceps without causing any injury to the patient, nor leaving any fragment/ part inside.The procedure was completed with a non-olympus forceps.It was stated that the defective forceps was not used to push organs nor any structure during the procedure, and that the users have been using the forceps for five years and consider themselves experienced with its use.There was no error on the generator.The patient experienced no injury or harm.Patient identifier (b)(6) is for the first instance of breakage.Patient identifier (b)(6) is for the second instance of breakage.
Additional Manufacturer Narrative
The device referenced in this report was not returned to olympus for evaluation.The root cause cannot be determined at this time.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 device returned for evaluation was model #pk-cf0533 and lot #fr263142 respectively.It was confirmed that one of the two jaws was broken-off.The insulation was also partially separated in several locations.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, the reported 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.The event can be detected/prevented by following the instructions for use (ifu) which state: "during the procedure, check the device and cord/cable regularly for damage.Inspect devices immediately upon removal from the patient for any signs of breakage or fragmentation.If the device is damaged, retain it to assist with the manufacturer¿s analysis of the event.Do not leave device fragments in the patient." this supplemental report includes a correction to d4, d9 and h3 from the initial medwatch.Also, additional information has been added to h4.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: 16765937
• Report Number: 3011050570-2023-00030
• Device Sequence Number: 11503009
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2023

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: FR263142
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 03/23/2023
• Supplement Date Received by Manufacturer: 12/01/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2022
• 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 -
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female