MAUDE Adverse Event Report: KARL STORZ ENDOVISION KARL STORZ; FLEXIBLE URETEROSCOPE

Model Number 11278AU1

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/19/2014

Event Type  malfunction  

Event Description

Allegedly, during a turp procedure, it was reported that the thermo insulation sleeve came out of distal end of the scope and was retrieved from the patient's kidney.The hospital used a competitor's resectoscope to complete the procedure.Patient is doing fine postop.

Manufacturer Narrative

The scope was evaluated and we found that it has been repaired by a third party.It has non-karl storz materials on the shaft, mask, and adhesive.There are deep scrape marks that punctured working channel and caused leaking.The field lens to bundle separation is due to corrosion, and corroded housing assembly caused the loss of deflection.It's missing thermo insulation sleeve was retrieved from patient, but it was not returned with the scope.The biomed later confirmed it was discarded.We suspect that missing sleeve has been repaired by a third party and is no longer karl storz material.

• Brand Name: KARL STORZ
• Type of Device: FLEXIBLE URETEROSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION; charlton MA
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA
• Manufacturer Contact: susie chen ; 2151 e. grand ave.; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 4232358
• MDR Text Key: 4999585
• Report Number: 1221826-2014-00051
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/25/2014

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: Health Professional
• Device Model Number: 11278AU1
• Device Catalogue Number: 11278AU1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/08/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2008
• 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
• Patient Age: 48 YR