MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE; URETERORENOSCOPE

Model Number WA29049A

Device Problem Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/05/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned to olympus for evaluation and the customer's allegation was confirmed.The evaluation found a bent outer tube, and a spot on the optical.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.

Event Description

The customer reported to olympus, at the outpatient surgery unit, during procedure, it was reported that the device-ureteroscope, 6,4/7,8 fr.X 330 mm, 7°, straight ocular angle, 4,2 fr.Channel, with wa00395a was bent at the end of the procedure when removing the scope.The procedure was ureteroscopy laser lithotripsy stenting undertaken and completed with the same device.The procedure was prolonged by 15 mins.Though there was a delay, this delay was reported to be a short one.There were no reports of patient harm or clinical impact associated with the reported event.No medical intervention was undertaken to preclude permanent harm/injury to the patient.There is no evidence of any serious deterioration in the state of health of the patient.Also, no indication of any life-threatening event occurred during the procedure.

• Brand Name: URETEROSCOPE
• Type of Device: URETERORENOSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, deutschland 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17875829
• MDR Text Key: 324984648
• Report Number: 9610773-2023-02817
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04042761063043
• UDI-Public: 04042761063043
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/05/2023

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
• Device Operator: Health Professional
• Device Model Number: WA29049A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1