MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS "HIQ+", 5 X 330 MM, GRASPING FORCEPS, CROCEOLMI

Model Number	WA64150A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during robot-assisted colectomy, the jaws unhinged when grasping a large piece of gauze.The procedure was completed with a similar device.Reports of the subject device unhinged when grasping a large piece of gauze and possibility that parts may have fallen out of the patient's body.The intended procedure was completed with a similar device.The patient's abdominal cavity was washed more carefully than usual.Xray was done and did not show anything resembling anything.There were no reports of patient injury/adverse events.There is no evidence that a life-threatening event occurred, that the patient developed permanent damage or impairment, and that additional medical/surgical intervention was done to prevent permanent damage or impairment.There were no reports of harm.
Additional Manufacturer Narrative
The subject device was returned to an olympus repair center for evaluation and the reported issue was confirmed.The device evaluation found that the drive shaft part of the forceps was broken.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
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 reported unhinged jaw issue was found to be due to a broken pull rod.A definitive root cause of the broken pull rod could not be determined, however, it is likely the issue was the result of mechanical overload due to excessive force exerted to the jaw.Olympus will continue to monitor field performance for this device.

• Brand Name: JAWS "HIQ+", 5 X 330 MM, GRASPING FORCEPS, CROCEOLMI
• Common Device Name: JAWS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17969764
• Report Number: 9610773-2023-03011
• Device Sequence Number: 6790910
• Product Code: HET
• UDI-Device Identifier: 04042761068970
• UDI-Public: 04042761068970
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944200
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2024

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: WA64150A
• Device Lot Number: 20X01-004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2023
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2023
• Supplement Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 03/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2021
• 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