MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG CYSTO-URETHROSCOPE SHEATH

Model Number 27026BA

Device Problems Bent (1059); Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Allegedly, the dr was performing a cystoscopy with retrograde procedure during which the distal end of the sheath broke off and fell into the pt's bladder.The dr removed the broken piece and procedure was completed.There was no impact to the pt.

Manufacturer Narrative

We evaluated the returned 27026ba sheath and the distal tip is completely broken off the shaft of the instrument and the shaft is severely bent.Damage is consistent with stress overload.

• Brand Name: CYSTO-URETHROSCOPE SHEATH
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG; tuttlingen ; GM
• Manufacturer (Section G): KARL STORZ GMBH & CO. KG; mittelstrasse 8; tuttlingen 7850 3; GM 78503
• Manufacturer Contact: susie chen, complaints ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 4531860
• MDR Text Key: 16556372
• Report Number: 9610617-2015-00012
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943668
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/16/2015

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: 27026BA
• Device Catalogue Number: SAME
• Device Lot Number: ZX01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/28/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2012
• 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
• Patient Outcome(s): Required Intervention