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

Model Number	WA64150A
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the jaws grasping croche forceps exhibited a break at the distal end while being used on a patient undergoing an esophageal procedure.The doctor sensed something unusual, mentioning that he heard a popping sound, and promptly withdrew the forceps, only to find the tip dangling.Upon removing the sheath to inspect the instrument, they discovered that one side of the hinge at the base of the opening and closing part had broken off, with a piece about 5 mm in size missing.Following this discovery, the operating room nurse and doctor collaborated to thoroughly clean the area and then checked for the missing part using an x-ray.Additionally, a ct scan was conducted after the surgery, but no foreign object was detected.The issue was found during a therapeutic esophageal procedure and the procedure was completed with a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the approved final investigation.The device history record was unable to be reviewed for this device since the lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, and since the device was not returned for evaluation, the definitive root cause of the reported issue could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: JAWS "HIQ+", 5 X 330 MM, GRASPING FORCEPS, CROCEOLMI
• Common Device Name: GRASPING FORCEPS
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19274909
• Report Number: 9610773-2024-01192
• Device Sequence Number: 15370873
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2024

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: N/A
• 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: 05/01/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 05/08/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female