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 Code	Temperature Problem (3022)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The provided lot code of the cord was gg01 which is from 07/01/2003 which is over the ifu recommendation and is probable cause of wear and tear causing energy to blow off the cable from the connection port of the instrument.The manufacture ifu states the "high frequency cables have a limited life span and recommends replacing hf cables every 3 months if used more than 2-3 procedures weekly".
Event or Problem Description
The manufactures reference number (b)(4).During a resection case on (b)(6), the cord 277kb blew off where it attaches to the resectoscope during the case and caught the drapes on fire.Per or manager in follow up reply noted that there was no fire involved, hole in drape.The patient was not harmed and was followed up in recovery.The cord was replaced and the procedure completed.

• 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: 15734579
• Report Number: 9610617-2022-00299
• Device Sequence Number: 16873358
• Product Code: GEI
• UDI-Device Identifier: 04048551090169
• UDI-Public: 4048551090169
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/04/2022

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: GG01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2003
• 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 Age: 69 YR
• Patient Sex: Male
• Patient Weight: 91 KG