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

Model Number 11278VU

Device Problem Material Disintegration (1177)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2015

Event Type  malfunction  

Manufacturer Narrative

We evaluated the returned scope and found thermal laser damage at distal tip of the scope.The angle cover is torn apart causing a leak.The up deflection was disabled from broken deflection wire in the handle housing.The thermal damage is consistent with a laser being discharged while passing laser fiber through working channel of the scope.

Event Description

Allegedly, during a cystoscopy with kidney stone ablation procedure using holmium laser, debris from scope was found inside patient's ureter.The surgeon removed debris using a stone basket.Procedure was completed with no patient injury.

• Brand Name: FLEX-XC VIDEO URETEROSCPE
• Type of Device: CMOS VIDEO URETEROSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 5106197
• MDR Text Key: 26831497
• Report Number: 1221826-2015-00076
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Report Date: 08/28/2015

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: Physician
• Device Model Number: 11278VU
• Device Catalogue Number: 11278VU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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