MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OUTER SHEATH, 8.5 MM / 26 FR., 2 STOPCOCKS, ROTATABLE; HYSTEROSCOPE (AND ACCESSORIES)

Model Number	A42021A
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while using the sheath with the high frequency unit, the high frequency unit exhibited an error (instrument cannot be recognized.Upon checking the plasma electric cutting interface, it was found that the interface was loose and suspected that poor interface contact had caused the malfunction.The issue occurred during an unknown therapeutic surgery.The procedure was completed using a similar device without delay.There were no reports of patient harm.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.This report is related to mfrs: 268569, 268577, 268582, 268588 and 268590.
Event or Problem Description
Additional information supplied by the customer.The malfunction was a plasma electric cutting interface malfunction, reporting an error message of an unrecognized instrument.The malfunction occurred before the surgery.Therapeutic surgery: the surgery was performed using another device of the same model.No delay.No injury incidents have occurred.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The device was not returned to olympus for inspection, so the customer's complaint/reportable malfunction was not confirmed.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: OUTER SHEATH, 8.5 MM / 26 FR., 2 STOPCOCKS, ROTATABLE
• Common Device Name: HYSTEROSCOPE (AND ACCESSORIES)
• 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: 20017247
• Report Number: 9610773-2024-01994
• Device Sequence Number: 17975892
• Product Code: HIH
• UDI-Device Identifier: 04042761023665
• UDI-Public: 04042761023665
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K897003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2024

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: A42021A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 07/31/2024
• Supplement Date Received by Manufacturer: 09/25/2024
• Initial Report FDA Received Date: 08/21/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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