MAUDE Adverse Event Report: KARL STORZ ENDOVISION FLEX XC; VIDEO URETEROSCOPE

Model Number	11278VSUAK
Medical Device Problem Code	Partial Blockage (1065)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hospital did not return the broken laser fiber piece for evaluation.They returned their video ureteroscope for an issue with the instrument channel.The channel was misaligned and there is an external cut on distal angle cover 40 mm from the tip causing an angle cover leak and debris on the vertebrae.There is a thermal melt mark on distal tip and channel wall is lifted.We cannot confirm how laser fiber broke.
Event or Problem Description
Allegedly, the doctor was performing a ureteroscopy with kidney stone removal on patient, when he attempted to introduce laser fiber; it wouldn't pass through the channel at first.Finally, they were able to pass it through, and a piece of the laser fiber broke off into the kidney.They used a wire basket to retrieve broken laser fiber piece and completed the case with no injury to the patient.
Event or Problem Description
This is a supplemental.I am correcting manufacturer and manufacturing site.No other corrections made.

• Brand Name: FLEX XC
• Common Device Name: VIDEO URETEROSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; 78503; charlton MA 01507
• MDR Report Key: 6661762
• Report Number: 1221826-2017-00043
• Device Sequence Number: 1615495
• Product Code: FGB
• UDI-Device Identifier: 04048551402603
• UDI-Public: 4048551402603
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K141250
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2017

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
• Operator of Device: Physician
• Device Model Number: 11278VSUAK
• Device Catalogue Number: 11278VSUAK
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/02/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/22/2017
• Supplement Report FDA Received Date: 06/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1