MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY SEMI-RIGID URETERO-RENOSCOPE

Model Number 27002LA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Internal Organ Perforation (1987); Excessive Tear Production (2235)

Event Date 07/17/2015

Event Type  Injury  

Manufacturer Narrative

Scope was not returned for evaluation.According to hospital's risk management, scope will not be released for evaluation and will remain in their possession.Hospital has not released product.

Event Description

Allegedly, doctor was performing a ureteroscopy, holmium laser lithotripsy for ureteral stones.At the end of procedure, upon removal of the scope by the surgeon, there was 17cm of the right ureter on the end of the scope.Patient was then taken to catheter lab for insertion of a right nephrostomy tube.Patient underwent a reconstructive surgery at a different hospital.Patient is doing well post reconstruction.

• Brand Name: SEMI-RIGID URETERO-RENOSCOPE
• Type of Device: URETERO-RENOSCOPE
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• Manufacturer (Section G): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 5231299
• MDR Text Key: 31447519
• Report Number: 9610617-2015-00097
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/20/2015

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
• Device Operator: Physician
• Device Model Number: 27002LA
• Device Catalogue Number: 27002LA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/20/2015
• Initial Date FDA Received: 11/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2009
• 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: 44 YR