MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH CYSTOSCOPE SHEATH, 22.5 FR.; ENDOSCOPE SHEATH, REUSABLE

Model Number	A20914A
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus that during insertion of non-olympus guidewire for a ureteral stent placement, the guidewire gets caught inside and was difficult to advance to the tip.The tip of the guidewire was probably caught in the mating area between the sheath and hebel bridge, as reported.The guidewire, whose tip had become bent due to a snag, was replaced with a new one, and the procedure was repeated several times to complete the procedure.The procedure was prolonged for one and a half to two times the normal length (usually about one hour).There were no reports of patient or user harm associated with this event.This event requires three reports.The patient identifiers are as follows: (b)(6)- (a20912a) cystoscope sheath.(b)(6)- (a20914a) cystoscope sheath.(b)(6)- (a20972a) endoscope assembly adaptor.This report is for (b)(6).
Additional Manufacturer Narrative
The subject devices were returned for evaluation.Olympus confirmed that the insertion part of the a20972a is slightly deformed.When the a20972a and a20914a were connected, and the guide wire of the examination equipment was inserted from the insertion part of the treatment tool, it was confirmed that there was resistance and insertion was difficult.When the a20972a and a20912a were connected, and the guide wire of the examination fixture was inserted from the insertion part of the treatment tool, it was confirmed that there was resistance, and it was difficult to insert.When the a20914a is connected, there is not enough space for the treatment tool to pass due to the positional relationship between the a20972a and the a20914a insertion part.The same is true for a20912a.If you replace it with a a20972a of examination equipment, the problem will be resolved, so it is considered that the cause is deformation of the a20972a.The cause of the deformation of the insertion part may be due to excessive force applied to the insertion part or the rear end side, but it was not identified.No abnormalities were observed in the a20912a.Although it could not be confirmed due to the shipping history, it is presumed that it was produced around 2004.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 correction to the initial with information inadvertently left out (updated fields g2 and h4).A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, it is likely the suggested event occurred due to the user.It is possible the described problem is directly related the age of the combination articles used and/or the deformation on the shaft tube of the working insert.However, a specific root cause of the suggested event could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: CYSTOSCOPE SHEATH, 22.5 FR.
• 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: 17952987
• Report Number: 9610773-2023-02971
• Device Sequence Number: 12701215
• Product Code: GCP
• UDI-Device Identifier: 04042761020268
• UDI-Public: 04042761020268
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K790071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2024

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: A20914A
• Device Lot Number: 46W-0126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 02/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2004
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SENSOR GUIDE WIRE (0.035 INCH, 150 CM)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown