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
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.This report is related to the following linked patient identifier: (b)(6).
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.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 and b2.B1 should not be marked as an adverse event, and b2 should not be marked at all.The f10 medical device problem reported and other findings would not cause or contribute to a death or a serious injury if it were to recur.Updated fields: f9 and f10.

• 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
• MDR Report Key: 21043402
• Report Number: 2429304-2024-01061
• Device Sequence Number: 15601952
• Product Code: GCP
• UDI-Device Identifier: 04042761029353
• UDI-Public: 04042761029353
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025
• Report Date (Section F): 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
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/24/2025
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2024
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2024
• Supplement Report FDA Received Date: 08/15/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/15/2025