MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS INSERT "HICURA", 5 X 330, CROCEOLMI, MONOPOLAR; RIGID ENDOSCOPIC TISSUE MANIPULATION FORCEPS

Model Number	WA69320M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus that during an unspecified therapeutic surgery, the tip of this forceps broke and fell into the patient's body.The broken part was recovered.The procedure was completed with similar device.There were no reports of further patient or user harm associated with this event.
Additional Manufacturer Narrative
This device was returned for evaluation and the allegation was confirmed.It was assumed that the forceps broke due to deterioration due to long-term use , overloading the forceps, or a combination of these.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out of the evaluation.The evaluation results are as followed: the mouth broke off at the thinnest point of the jaw insert.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, it is likely the subject device broke and fell into the patient's body during procedure occurred due to the application of excessive force and wear and tear.However, the root cause of the suggested event could not be identified.Olympus will continue to monitor field performance for this device.

• Brand Name: JAWS INSERT "HICURA", 5 X 330, CROCEOLMI, MONOPOLAR
• Common Device Name: RIGID ENDOSCOPIC TISSUE MANIPULATION 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: 17246550
• Report Number: 9610773-2023-01789
• Device Sequence Number: 17342229
• Product Code: GEI
• UDI-Device Identifier: 04042761079297
• UDI-Public: 04042761079297
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140624
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2023

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: WA69320M
• Device Catalogue Number: WA69320M
• Device Lot Number: 159W-0019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2023
• 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: 06/05/2023
• Supplement Date Received by Manufacturer: 09/25/2023
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2015
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown