MAUDE Adverse Event Report: KARL STORZ 22 FR CYSTOSCOPE SHEATH

Model Number 27086BA

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 03/17/2016

Event Type  Injury  

Event Description

Pt was undergoing cystoscopy and end of cystoscope sheath fractured off. Defect noted to be at weld site.

• Brand Name: 22 FR CYSTOSCOPE SHEATH
• Type of Device: 22 FR CYSTOSCOPE SHEATH
• Manufacturer (Section D): KARL STORZ; charleton MA 01507
• MDR Report Key: 5517449
• MDR Text Key: 40937038
• Report Number: MW5061095
• Device Sequence Number: 1
• Product Code: FAJ

Combination Product (Y/N)

• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: NURSE
• Type of Report: Initial
• Report Date: 03/18/2016

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 03/18/2016
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device MODEL Number: 27086BA
• Was Device Available For Evaluation?: No Answer Provided
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Was Device Evaluated By Manufacturer?: No Answer Provided
• Is The Device Single Use?: No Answer Provided
• Is this a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient TREATMENT DATA

Date Received: 03/18/2016 Patient Sequence Number: 1