MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OUTER SHEATH, 8.5 MM / 26 FR., 2 STOPCOCKS, ROTATABLE; ENDOSCOPE SHEATH, REUSABLE

Model Number	A42021A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus that an electrical failure occurred and no image during the hysteroscopic myomectomy and the same problem occurred after replacing all the combined devices causing a 30-minute delay in surgery and 30 minutes extended anesthesia time.There were no error messages.The procedure was completed using other urological products.The event did not affect the diagnostic or treatment outcome.There were no reports of patient harm.This event requires 12 reports.Related patient identifiers for the first combination of devices used are as follows: (b)(6) (wa00014a / hf-cable, bipolar), (b)(6) (wa00014a / hf-cable, bipolar) , (b)(6) (a42011a / resection sheath, 8 mm, for 8.5 mm/26 fr.Outer sheath, abs), (b)(6) (a42021a / outer sheath, 8.5 mm / 26 fr., 2 stopcocks, rotatable), (b)(6) (wa22366a /working element, active, for resection in saline), (b)(6) (wb50402w / foot switch, double, for, esg-400).Related patient identifiers for the second combination of devices used: (b)(6) (wb50402w / foot switch, double, for, esg-400), (b)(6) (wa22366a / working element, active, for resection in saline), (b)(6) (a42011a / resection sheath, 8 mm, for 8.5 mm/26 fr.Outer sheath, abs), (b)(6) (a42021a /outer sheath, 8.5 mm / 26 fr., 2 stopcocks, rotatable), (b)(6) (wa00014a / hf-cable, bipolar), (b)(6) (wa00014a /hf-cable, bipolar).This medwatch report is for patient identifier:(b)(6).
Additional Manufacturer Narrative
The device was not returned for analysis.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 device evaluation.The device was returned to olympus for inspection, and the customer¿s complaint could not be reproduced.The evaluation findings are as follows: there were no abnormalities observed.In addition, no electrical problems were confirmed, and the output was normal.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 2 years since the subject device was manufactured.Based on the results of the investigation, the cause of the reported issue could not be determined as no device fault or malfunction was identified by olympus.Although no device problem was detected, potential causes for poor conductivity may be dirt adhering to the electrodes (impairing conduction), a temporary poor connection of the device, and/or an abnormality in the high-frequency power.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: ENDOSCOPE SHEATH, REUSABLE
• 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: 17372159
• Report Number: 9610773-2023-01944
• Device Sequence Number: 3784160
• Product Code: HIH
• UDI-Device Identifier: 04042761023665
• UDI-Public: 04042761023665
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K897003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: A42021A
• Device Catalogue Number: A42021A
• Device Lot Number: 20X04-0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2020
• 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: Other
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian