MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MONOPOLAR ELECTRODE; STERILE MONOPOLAR ELECTRODE, 1MM

Model Number 11161AB-S

Device Problem Intermittent Loss of Power (4016)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

It was reported that the customer had three incidents involving part # 11161ab-s (bugbee electrode).The item worked either intermittently or not at all, during our investigation of the event, the facility had no further information to provide.

Manufacturer Narrative

The device has not been returned for evaluation.Per the customer the electrode was used with our 26006m but they also tried to troubleshoot with an aesculap monopolar cable.Our sales representative went to the account and tested the electrode with both cords and everything worked.

• Brand Name: MONOPOLAR ELECTRODE
• Type of Device: STERILE MONOPOLAR ELECTRODE, 1MM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242118810
• MDR Report Key: 13826708
• MDR Text Key: 292980032
• Report Number: 9610617-2022-00028
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04048551392546
• UDI-Public: 4048551392546
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11161AB-S
• Device Catalogue Number: 11161AB-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1