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

Model Number	11161AB-S
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	Brain Injury (2219)
Date of Event	01/17/2022
Type of Reportable Event	Death
Additional Manufacturer Narrative
The device has not been returned for evaluation as of yet.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.
Event or Problem Description
It was reported that the customer had three incidents involving part # 11161ab-s (bugbee electrode) - one of them leading to a passing of a patient.The item worked either intermittently or not at all.During our investigation of the event, the facility stated profound brain damage, and the family decide to withdraw help.Reason: neurological devastation.

• Brand Name: MONOPOLAR ELECTRODE
• Common Device Name: 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: 13725281
• Report Number: 9610617-2022-00023
• Device Sequence Number: 12254687
• Product Code: GEI
• UDI-Device Identifier: 04048551392546
• UDI-Public: 4048551392546
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K972497
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 11161AB-S
• Device Catalogue Number: 11161AB-S
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2022
• Initial Report FDA Received Date: 03/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown