MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH OUTER SHEATH, 26 FR., 2 STOPCOCKS, VERTICAL, FIXED; A22027A

Model Number	A22027A
Medical Device Problem Codes	Break (1069); Dent in Material (2526); Material Twisted/Bent (2981); Failure to Seal (4070)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report has been submitted by the importer under this mdr report number 2429304-2024-01061.This report is related to the following linked patient identifier: (b)(6).The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported that during a cystoscopy, the subject device had exhibited not sealing, a couple of dents, it was bent and the lock was broken.This issue resulted in delay of the procedure for more than 30 minutes while the patient was under sedation.The procedure was completed with an olympus back-up device.There were no reports of patient harm.
Event or Problem Description
Additional information was received from the customer which confirmed that the event happened before the start of the procedure.There were no reports of patient harm from the prolonged procedure.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide correction, additional information and the results of the legal manufacturer's final investigation.Updated fields: b5, d9, h3, h4 and h6.Corrections to b1, b2, and h1.This event was initially conservatively reported as a serious injury; however, upon further follow-up, the customer confirmed that the patient did not suffer any serious injury or adverse effects from the prolonged procedure, thus correcting b1, b2, and h1.B1 should not be marked as an adverse event, and b2 should not be marked at all.H1 should also not be marked.The h6 medical device problem reported and other findings would not cause or contribute to a death or a serious injury if it were to recur.The device was returned to olympus for inspection and the reported failure was confirmed.A visual inspection and functional tests was performed and confirmed the reported issues, finding dents in the sheath and broken locking ring.Based on the results of the investigation, the definitive root cause of the reported issue could not be determined.The likely cause of the reported problem was due to a component failure, or a random component failure without any design or manufacturing issue.Should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor field performance for this device.

• Brand Name: OUTER SHEATH, 26 FR., 2 STOPCOCKS, VERTICAL, FIXED
• Common Device Name: A22027A
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 21043344
• Report Number: 9610773-2024-34384
• Device Sequence Number: 8539031
• Product Code: GCP
• UDI-Device Identifier: 04042761029353
• UDI-Public: 04042761029353
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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: A22027A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/02/2024
• Supplement Date Received by Manufacturer: 07/24/2025
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 08/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2023
• 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