MAUDE Adverse Event Report: KARL STORZ ENDOVISION URETERO-RENO-FIBERSCOPE FLEX-X2; URETEROSCOPE

Model Number	11278AU1
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	06/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Our evaluation found that scope angle cover is elongated, expanded and has puncture holes in the angle cover.The working channel is punctured and is leaking.Scope is flooded in handle housing.Deflection fails at 180° up and 240° down.There is moisture in eyepiece causing a foggy image.There is an over bend on proximal shaft 50mm from shaft adaptor.We think it possible that this device was not vented during eto sterilization which can result in damage to the scope: our ifu states to "place the red pressure compensation cap on the vent port before eto gas sterilization".The eto system pulls a vacuum during the process, and if not vented, scope damage may occur.Specifically at the angle cover as this is the most pliable material on the shaft.
Event or Problem Description
Allegedly, the doctor reported that she was performing a ureteroscopy w/kidney stone removal on a patient and when she removed the scope from the patient the ureter was punctured and torn.Doctor was 3/4 of the way into the case and had to abort the case early, since patient's ureter was injured and her view was obstructed as a result of the protruded and bubbled sheathing at distal end of the scope.They were unable to place a stent at that time.Doctor confirmed the injury on (b)(6) 2017; wall of the ureter was punctured and torn.They had to insert a percutaneous nephrostomy tube or catheter inside patient's kidney to drain urine and insert a percutaneous antigrade stent.Patient was discharged from hospital on (b)(6) 2017 and scheduled to come back for a follow-up on (b)(6) 2017 to have nephrostomy tube removed.Doctor will be monitoring patient's progress.

• Brand Name: URETERO-RENO-FIBERSCOPE FLEX-X2
• Common Device Name: URETEROSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• MDR Report Key: 6734291
• Report Number: 1221826-2017-00058
• Device Sequence Number: 817140
• Product Code: FGB
• UDI-Device Identifier: 04048551226438
• UDI-Public: 4048551226438
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K982905
• 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
• Report Date (Section B): 06/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Physician
• Device Model Number: 11278AU1
• Device Catalogue Number: 11278AU1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2017
• Initial Report FDA Received Date: 07/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other
• Patient Age: 13 YR
• Patient Weight: 83