MAUDE Adverse Event Report: GYRUS ACMI, INC. PK CUTTING FORCEPS, 5MM, 33CM; ENDOSCOPIC ELECTROSURGICAL HANDPIECE/ELECTRODE, BIPOLAR, SINGLE-USE

Model Number	PK-CF0533
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been returned to olympus at this time.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
An olympus representative reported to olympus on behalf of the customer that the top jaw of the cutting forceps broke off and fell into the patient during a laparoscopic hysterectomy.The physician indicated that the forceps was used to do modest dissection into the fibrotic tissues seen typically around the uterine arteries and that the forceps were "too flimsy".The broken piece was retrieved, and the procedure was completed without delay using another forceps.There was no further harm or user injury reported due to the event.
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 no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, since the device was not returned for evaluation, a root cause of the reported event could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: "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 b5 and d8 to provide information that was inadvertently not included on the initial medwatch.Olympus will continue to monitor field performance for this device.
Event or Problem Description
It was confirmed by the facility that the devices were inspected prior to use with no abnormalities observed.Patient demographics are unavailable.
Additional Manufacturer Narrative
The initial medwatch incorrectly reported the site registration number.The site registration number is 3011050570.

• Brand Name: PK CUTTING FORCEPS, 5MM, 33CM
• Common Device Name: ENDOSCOPIC ELECTROSURGICAL HANDPIECE/ELECTRODE, BIPOLAR, SINGLE-USE
• 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: 16153986
• Report Number: 3005975494-2023-00013
• Device Sequence Number: 15344110
• Product Code: GEI
• UDI-Device Identifier: 00821925035867
• UDI-Public: 00821925035867
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/22/2023

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: FR258486
• Was Device Available for Evaluation?: No
• 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: 12/16/2022
• Supplement Date Received by Manufacturer: 02/17/2023; 05/01/2023
• Initial Report FDA Received Date: 01/12/2023
• Supplement Report FDA Received Date: 03/01/2023; 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female