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

Model Number 27176LEB

Device Problem Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2014

Event Type  malfunction  

Event Description

Allegedly, the doctor was starting a turp procedure; when he activated instrumentation he heard a loud noise and saw arcing emitting from cable where it was attached to the esu.Operating room personnel swapped out instrumentation and completed procedure with replacements.There was no injury to the patient; patient condition post op was good.

Manufacturer Narrative

The bipolar power cable had a hole in the plug side that attaches to resection module on the esu.It was damaged internally.The instrument was most likely flash sterilized right before the procedure and may have retained moisture.

• Brand Name: BIPOLAR CABLE
• Type of Device: CABLE
• Manufacturer (Section D): KARL STORZ GMBH & CO.; tuttlingen ; GM
• Manufacturer (Section G): KARL STORZ GMBH & CO. KG; mittlestrasse 8; tuttlingen 7850 3; GM 78503
• Manufacturer Contact: susie chen ; 2151 e. grand ave.; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 4379157
• MDR Text Key: 5115952
• Report Number: 9610617-2014-00069
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/24/2014

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: 27176LEB
• Device Catalogue Number: 27176LEB
• Device Lot Number: 06/2012
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/22/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR