MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MONOPOLAR HIGH FREQUENCY CORD; HIIGH FREQUENCY CORD, 8MM PLUG MONOPOLAR

Model Number	277KB
Medical Device Problem Codes	Electrical /Electronic Property Problem (1198); Flare or Flash (2942)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product has not been returned; therefore, product has not been evaluated.The provided lot code of the cord was yx which is from 11/2012 which is over the ifu recommendation and is probable cause of wear and tear causing a spark.
Event or Problem Description
Per the salesrep during a bladder/prostate resection, when activating the esu fire/explosion occurred at the instrument and was quickly extinguished.No injury to patient or to staff reported.The cord was replaced and the procedure completed.
Additional Manufacturer Narrative
Per evaluation the distal connector of the cord is missing.Approximately, where the connector would be, the end of the wire is burnt.The shaft of the proximal end is scratched.There is customer markings on the connector.Signs of customer use: yes.Evidence of use: missing connector, burnt wire, scratched connector.

• Brand Name: MONOPOLAR HIGH FREQUENCY CORD
• Common Device Name: HIIGH FREQUENCY CORD, 8MM PLUG MONOPOLAR
• 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, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188100
• MDR Report Key: 15259949
• Report Number: 9610617-2022-00248
• Device Sequence Number: 5787072
• Product Code: GEI
• UDI-Device Identifier: 04048551090169
• UDI-Public: 4048551090169
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2022

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: YX
• 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: 07/22/2022
• Supplement Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 08/19/2022
• Supplement Report FDA Received Date: 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2012
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male