MAUDE Adverse Event Report: KARL STORZ GMBH & CO. HOPKINS II TELESCOPE

Model Number 27005BA

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/02/2015

Event Type  malfunction  

Manufacturer Narrative

The metal on distal end of scope is burnt and melted; a small piece on distal end is broken off.The objective lens & distal end seal are compromised.The distal window is broken on the scope.The wire of the cutting loop melted on one side of the resectoscope & damaged telescope.It is possible settings were too high.

Event Description

Allegedly, doctor was performing a transurethral resection of a bladder tumor, when the wire of the cutting loop melted on one side and damaged telescope, and a piece of distal end of scope broke in the patient.The small piece was retrieved.Procedure was completed.There was no report of injury.

• Brand Name: HOPKINS II TELESCOPE
• Type of Device: TELESCOPE
• Manufacturer (Section D): KARL STORZ GMBH & CO.; tuttlingen ; GM
• Manufacturer Contact: susie chen ; mittelstrasse 8; tuttlingen ; GM ; 4242188201
• MDR Report Key: 4987724
• MDR Text Key: 23271814
• Report Number: 9610617-2015-00061
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943176
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Report Date: 07/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27005BA
• Device Catalogue Number: 27005BA
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/09/2015
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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