MAUDE Adverse Event Report: GYRUS ACMI, INC DISSECTOR FCP,5MM/33CM (5/PK)

Model Number	3700
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, during a bso (bilaterial salpingo oopherectomy) therapeutic procedure, the surgeon was dissecting soft fatty tissue when the jaw tip broke off.The surgeon could not find and could not retrieve the broken piece in the abdominal cavity.According to reporter, " the surgeon (general surgeon) was performing a bso on the patient.While dissecting soft fatty tissue the tip of the jaw broke off clean.The event was detected when the surgeon wanted to continue dissecting.The broken jaw piece was left behind in the abdominal cavity".According to the reporter " surgeon did not retrieve the tip as the potential adverse side effect would be greater than leaving the blunt and sterile tip behind".There was no patient harm or injury reported ,no user injury reported.
Additional Manufacturer Narrative
Follow up communication with the customer regarding the event reported conveyed the following information : june 02, 2022, representative noted : as per the information received from the customer: the doctor was unable to retrieve the fractured piece from the patient.Further correspondence was received from the surgeon through our sales representative and the patient did not have any post operative complications this point.No x-rays were taken after the procedure.The subject device was returned to sbc olympus (service business center ) for evaluation and on the way to legal manufacturer for investigation.Supplemental report(s) will be submitted should any relevant new information is available and or received.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation, the device evaluation and d4 correction.D4: corrected the udi.The device evaluation found the device handle and shaft were in good condition without physical damage.The handle is able to smoothly open and close.However, one of the jaws was fractured off at the jaw leg.The fractured off section was not returned to olympus.Further the device functionality could not be tested due to the missing jaw.As a result, the initial complaint of the jaw tip breaking off can be confirmed.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 observed failure likely occurred from having inadvertent movement near the distal tip of the device jaws causing excessive stress resulting in jaw damage which may be traced to lack of visual insight from the device during use.The following information is stated in the instructions for use (ifu): "keep the device tip in sight during use.Inadvertent activation or movement of the device outside the field of vision may result in patient injury." olympus will continue to monitor field performance for this device.

• Brand Name: DISSECTOR FCP,5MM/33CM (5/PK)
• Common Device Name: DISSECTOR FCP
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: brian motter ; 9600 louisiana avenue north; brooklyn park, MN 55445 ; 4848965250
• MDR Report Key: 14614798
• Report Number: 3011050570-2022-00072
• Device Sequence Number: 17286702
• Product Code: GEI
• UDI-Device Identifier: 00821925035928
• UDI-Public: 00821925035928
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K031080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3700
• Device Lot Number: FR155518
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2021
• 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
• Patient Age: 60 YR
• Patient Sex: Female