MAUDE Adverse Event Report: KARL STORZ GMBH & CO. KG BIPOLAR ELECTRODES; BIPOLAR CUTTING LOOP

Model Number 27040GP1

Device Problems Thermal Decomposition of Device (1071); Charred (1086); Arcing of Electrodes (2289)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/15/2014

Event Type  malfunction  

Event Description

Allegedly, the doctor was performing a turp when he activated electrodes, 7 arced and broke inside of pt; no material fell into pt.He replaced the electrodes and went on to complete procedure.There was no injury to pt; pt condition post-op was good.

Manufacturer Narrative

The esu (autocon) that provides power to these electrodes was over activated.The duty cycle of 25% (10 seconds on/30 seconds off) was not adhered to which caused damage to the generator resulting in a surge which damaged the electrodes.

• Brand Name: BIPOLAR ELECTRODES
• Type of Device: BIPOLAR CUTTING LOOP
• 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 ave.; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 4268639
• MDR Text Key: 5298840
• Report Number: 9610617-2014-00056
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27040GP1
• Device Catalogue Number: SAME
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/02/2014
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR