MAUDE Adverse Event Report: KARL STORZ SE & CO. KG UNIPOLAR HIGH FREQUENCY CORD, 300 CM

Model Number	277KB
Medical Device Problem Codes	Material Separation (1562); Sparking (2595); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a broken lead blew up during a procedure.No negative impact in state of health reported.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
Additional information was provided that the cable end was burned and damaged.
Additional Manufacturer Narrative
Device evaluation: during the investigation, the cable was cut in half.The instrument plug was missing and not available for investigation.The cable wires shows residues of soot as well as corroded cable ends.Only a few strands shows typical copper color.This means, that only these few strands can provide voltage and current to the instrument.It is concluded that the most probable root cause is the aging of the cable.The cable is more than 7 years old and is therefore most likely that the cable has reached the end of its useful life.In the corresponding instructions for use the following safety relevant information regarding the failure of products is stated: the product may fail during use.Have a replacement product ready for each application or plan for an alternative surgical technique the event is filed under internal karl storz complaint id:(b)(4).

• Brand Name: UNIPOLAR HIGH FREQUENCY CORD, 300 CM
• Common Device Name: UNIPOLAR HIGH FREQUENCY CORD
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 19521816
• Report Number: 9610617-2024-00171
• Device Sequence Number: 18227019
• Product Code: GEI
• UDI-Device Identifier: 04048551090169
• UDI-Public: 4048551090169
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K945380
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 277KB
• Device Catalogue Number: 277KB
• Device Lot Number: NS01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2024
• Supplement Date Received by Manufacturer: 06/17/2024; 08/22/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 06/27/2024; 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/15/2017
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown