MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE, 8,6/9,8 FR. X 430 MM, 7°, 6,4 FR. CHANNEL, WITH WA00396A; URETEROSCOPES,AUTOCLAVABLE

Model Number WA29042A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/19/2015

Event Type  malfunction  

Manufacturer Narrative

The suspect medical device was not returned to olympus for evaluation/investigation as it is still being used by the user facility.Therefore the exact cause of the user's experience and the reported phenomenon could not be determined and is being judged as unknown.However, it was reported that the operating surgeon accidentally grabbed the urethral wall with the basket when he captured the fragments of the bladder stone.This probably caused the ureteroscope and the stone retrieval basket to get stuck.The case will be closed from olympus side with no further actions but may be reopened if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available at a later time.Then, this report will be updated.Furthermore, the reported phenomenon will be recorded for trending and surveillance purposes.

Event Description

Olympus was informed that during a therapeutic transurethral lithotripsy (tul) procedure, the ureteroscope and the stone retrieval basket got stuck inside the patient's urethra while attempting to capture and retrieve the fragments of a bladder stone.The distal end of the stone retrieval basket was then cut off.The complete set of equipment remained inside the patient until the next day, when it was removed.No further information was provided but there was no report about an adverse event or patient injury.In addition, the patient is reportedly doing well.

• Brand Name: URETEROSCOPE, 8,6/9,8 FR. X 430 MM, 7°, 6,4 FR. CHANNEL, WITH WA00396A
• Type of Device: URETEROSCOPES,AUTOCLAVABLE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, 22045 ; GM 22045
• Manufacturer Contact: daniel wladow ; kuehnstrasse 61; hamburg, 22045 ; GM 22045 ; 40 66966
• MDR Report Key: 5267020
• MDR Text Key: 32976759
• Report Number: 9610773-2015-00059
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K951855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/04/2015

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: WA29042A
• Device Catalogue Number: WA29042A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/19/2015
• Initial Date FDA Received: 12/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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