MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE, 7.3/10.4 FR. X 430 MM, 5°, ANGLED OCULAR, 6.4 FR. CHANNEL; RIGID SCOPE

Model Number	WA2UR14A
Medical Device Problem Codes	Material Fragmentation (1261); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect medical device has not yet been returned to olympus for evaluation/investigation.Therefore, the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
Event or Problem Description
Olympus was informed that during a therapeutic laser lithotripsy procedure, the cover glass of the ureteroscope detached and fell into the patient.However, no fragment remained inside the patient since it was reportedly retrieved.No further information was provided, but there was no report about an adverse event or patient injury.
Additional Manufacturer Narrative
The suspect medical device was returned to the manufacturer for evaluation/investigation.The evaluation/investigation confirmed that the cover glass of the ureteroscope¿s outer tube got detached.The cover glass itself was not provided for investigation.The investigation showed that the defect was most likely due to contamination and the resulting detachment of the instrument's gold coating, which in turn caused the separation of the cover glass.There is currently no evidence for user error or a systematic issue, rather the fault is considered a single and isolated issue during the manufacturing process.The reported event/incident will be recorded for trending and surveillance purposes and the user will be informed about the investigation results.

• Brand Name: URETEROSCOPE, 7.3/10.4 FR. X 430 MM, 5°, ANGLED OCULAR, 6.4 FR. CHANNEL
• Common Device Name: RIGID SCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg 22045 ; GM 22045 ; 4940669662955
• MDR Report Key: 12655575
• Report Number: 9610773-2021-00296
• Device Sequence Number: 4713769
• Product Code: FGB
• UDI-Device Identifier: 04042761086363
• UDI-Public: 04042761086363
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K200369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: WA2UR14A
• Device Catalogue Number: WA2UR14A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 03/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown