MAUDE Adverse Event Report: GYRUS ACMI, INC. GRASPING FORCEPS, NEEDLE HOLDER, 5 X 300 MM, INLINE HANDLE; SUTURING NEEDLE HOLDER, REUSABLE

Model Number	A5690
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the subject device did not work properly during a clinical procedure.The tip of the device did not fully close resulting in a slight gap.There was no harm or user injury reported due to the event.
Additional Manufacturer Narrative
The suspect device was sent to olympus for evaluation.Inspection and testing confirmed the jaws would not fully close resulting in a slight gap when the handle was fully locked in place.There was play in the handle grip and locking ratchet mechanism.To close the jaws, the handle must be squeezed all the way and slid past overlapping of the interlocking teeth.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
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.Based on the results of the investigation, the definitive root cause of the incomplete closure could not be determined.It is possible that the event occurred due to the application of excessive force during use.Olympus will continue to monitor field performance for this device.

• Brand Name: GRASPING FORCEPS, NEEDLE HOLDER, 5 X 300 MM, INLINE HANDLE
• Common Device Name: SUTURING NEEDLE HOLDER, REUSABLE
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16506637
• Report Number: 3003790304-2023-00115
• Device Sequence Number: 16982622
• Product Code: GCJ
• UDI-Device Identifier: 04042761052801
• UDI-Public: 04042761052801
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K912362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2023

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: A5690
• Device Catalogue Number: WA56900A
• Device Lot Number: 214W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2023
• 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: 05/23/2022
• Supplement Date Received by Manufacturer: 03/23/2023
• Initial Report FDA Received Date: 03/08/2023
• Supplement Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown