MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH BRIDGE, TWO WAY; A20977A

Model Number	A20977A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during cystoscopy, this subject device broke during the procedure while the patient was under sedation.As a result, the procedure was prolonged for more than 30 minutes.It is unknown if the procedure was completed using a different device.There were no reports of patient harm.
Additional Manufacturer Narrative
The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the customer and the results of the legal manufacturer¿s investigation.Updated fields: b5, d8, h2, h4, h6, and h11.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 no returned to olympus for evaluation and the complaint was not confirmed.Cause cannot be established due to no findings available.Olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported there was no patient injury due to the surgical prolongation.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide correction.
Event or Problem Description
It was reported that the cystoscope bridge broke on its first use of intervention.The tap broke while the user was trying to open it to give water debit to the system.

• Brand Name: BRIDGE, TWO WAY
• Common Device Name: A20977A
• 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 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20898104
• Report Number: 9610773-2024-33801
• Device Sequence Number: 5052457
• Product Code: GCP
• UDI-Device Identifier: 04042761020404
• UDI-Public: 04042761020404
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2025

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: A20977A
• Device Lot Number: 174W-0200/17RJ
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 03/31/2025; 11/05/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 04/16/2025; 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2017
• 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