MAUDE Adverse Event Report: KARL STORZ GMBH CO. KG BIPOLAR CAUTERY LOOP CABLE; ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL

Model Number 27040GP1-S

Device Problems Overheating of Device (1437); Material Split, Cut or Torn (4008)

Patient Problem No Information (3190)

Event Date 01/31/2019

Event Type  malfunction  

Event Description

There appears to be an over-heating and a splitting toward the end of the cable.In addition to the device listed under the device section, we have had a similar event with a cable from #: (b)(4), lot# rr01-02951.

• Brand Name: BIPOLAR CAUTERY LOOP CABLE
• Type of Device: ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
• Manufacturer (Section D): KARL STORZ GMBH CO. KG; 2151 e. grand avenue; el segundo CA 90245 5017
• MDR Report Key: 8499727
• MDR Text Key: 141480497
• Report Number: 8499727
• Device Sequence Number: 1
• Product Code: FAS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27040GP1-S
• Device Lot Number: RR01-03128
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 24090 DA