MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH JAWS INSERT "HICURA", 5 X 330, METZENBAUM, MONOPOLAR; HAND INSTRUMENTS

Model Number	WA69370M
Medical Device Problem Code	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 is pending return for evaluation.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.
Event or Problem Description
The customer reported that when using a shaft ¿hicura¿, 5 x 330, monopolar, the shaft (the ball at the distal end of the inlay) detached from the handle, and the shaft and inlay could not be removed from the trocar.The user then closed the branches of the scissors from another trocar with pliers to remove the inlay and pipe shaft.The event occurred during the therapeutic (laparoscopic) procedure and was completed with a similar device.There was no patient harm associated with the event.The report is linked to patient identifiers: (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was returned to olympus for inspection, and the customer¿s complaint was 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 root cause of the reported event was determined to be the hicura scissors has a week point regarding the retaining function of the connection between jaw insert and handle regarding transmission of the cutting force.It is also assumed that over time the closing force drifted out of specification.Furthermore, it is also likely the high flexibility of the proximal end of the jaw insert, which is required to ensure an easy assembling of the instrument and to prevent damage of the proximal end, is also increasing the likelihood of the occurred phenomenon.A design change has been initiated to prevent further occurrences.Olympus will continue to monitor field performance for this device.

• Brand Name: JAWS INSERT "HICURA", 5 X 330, METZENBAUM, MONOPOLAR
• Common Device Name: HAND INSTRUMENTS
• 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: 17710109
• Report Number: 9610773-2023-02499
• Device Sequence Number: 11300048
• Product Code: GEI
• UDI-Device Identifier: 04042761079761
• UDI-Public: 04042761079761
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2023

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: WA69370M
• Device Lot Number: 23102-023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/09/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/10/2023
• 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