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

Model Number 27040GP1

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2015

Event Type  malfunction  

Event Description

Allegedly, the doctor was performing a turp when he noted that a spark and smoke were seen emitting from the distal end of the device while the instrumentation was inside the patient.The electrode was removed and replaced and the procedure was completed; there was no injury to the patient.

Manufacturer Narrative

We cannot confirm cause; it is possible that settings were too high or some tissue became caught and caused smoking and spark.

• Brand Name: BIPOLAR ELECTRODES
• Type of Device: BIPOLAR CUTTING LOOP
• Manufacturer (Section D): KARL STORZ GMBH & CO.; 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: 4613821
• MDR Text Key: 16304872
• Report Number: 9610617-2015-00019
• 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: 02/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• 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: 27040GP1
• Device Lot Number: 48937
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/03/2015
• 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