MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG BIPOLAR CABLE

Model Number 27176LEB

Device Problem Electrical Shorting (2926)

Patient Problem Muscle Spasm(s) (1966)

Event Date 06/10/2014

Event Type  malfunction  

Event Description

Allegedly, the doctor was performing a turp when he noted that the patient "bucked" as if shocked.He removed the instrumentation and found that the connector on the bipolar cable had become damaged and some of the material appeared melted; part of the proximal end of the electrode was fused with the cable.The doctor replaced the cable and the electrode and went on to complete the procedure.There was no injury to the patient; patient condition post-op was fine.

Manufacturer Narrative

The bipolar cable was returned and condition noted; damaged and material melted; it will be sent to the manufacturer for evaluation.

• Brand Name: BIPOLAR CABLE
• Type of Device: BIPOLAR CABLE
• Manufacturer (Section D): KARL STORZ GMBH & CO. KG; tuttlingen ; GM
• Manufacturer (Section G): KARL STORZ GMBH & CO. KG; mittelstrasse 8; tuttlingen 7850 3; GM 78503
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4248188201
• MDR Report Key: 4092754
• MDR Text Key: 19089411
• Report Number: 9610617-2014-00034
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27176LEB
• Device Catalogue Number: SAME
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2013
• 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: 70 YR