MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. RESECTOSCOPE SHEATH

Model Number 27040XA

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/07/2016

Event Type  malfunction  

Event Description

The insulated tip of the storz continuous flow on the resectoscope fell off into patient's bladder.The piece was retrieved.Per doctor, no signs or symptoms of trauma was observed.

• Brand Name: RESECTOSCOPE SHEATH
• Type of Device: RESECTOSCOPE
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.; 2151 e. grand avenue; el segundo CA 90245
• MDR Report Key: 6102315
• MDR Text Key: 59901264
• Report Number: 6102315
• Device Sequence Number: 1
• Product Code: FJL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/07/2016,10/10/2016

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: No Information
• Device Model Number: 27040XA
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/07/2016
• Event Location: Hospital
• Date Report to Manufacturer: 10/07/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/15/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 78 YR