MAUDE Adverse Event Report: KARL STORZ SE & CO. KG WORKING ELEMENT; MONOPOLAR WORKING ELEMENT

Model Number	27050E
Medical Device Problem Codes	Temperature Problem (3022); Excessive Heating (4030)
Health Effect - Clinical Codes	Burn(s) (1757); Blister (4537)
Date of Event	12/22/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event is filed under internal karl storz complaint id (b)(4).The evidence of a third-party repair to the shaft which is attached to the block was noted.The socket block was found to have oxidized metal inside, this socket block is attached to the shaft and where the high frequency cord is plugged into.The lot code of xy (10/201 is well over the warranty period).
Event or Problem Description
It was reported that there was an event with a 27050e monopolar working element.According to the information received, doctor burned her hand when touching the casing (white plastic part on the working element) it was extremely hot.The shaft was not hot.The facility stated the doctor had a second degree burn with blisters.
Additional Manufacturer Narrative
The event is filed under internal karl storz complaint id (b)(4).The cause of the damage is due to the user.In the teflon block are shimmering through black, this indicates a short circuit combustion inside.In addition, the contact is very corroded.The lock nut is broken.Since the article was already manufactured in october 2011 and it has a corresponding number of application behind it.0 similar complaints in the period of 01.01.2019 - 02.05.2023.

• Brand Name: WORKING ELEMENT
• Common Device Name: MONOPOLAR WORKING ELEMENT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; 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
• MDR Report Key: 16396754
• Report Number: 9610617-2023-00032
• Device Sequence Number: 5544046
• Product Code: HIH
• UDI-Device Identifier: 04048551077542
• UDI-Public: 4048551077542
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K882270
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2023

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: 27050E
• Device Catalogue Number: 27050E
• Device Lot Number: XY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 02/17/2023
• Supplement Report FDA Received Date: 05/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2011
• 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: 83 YR
• Patient Sex: Male
• Patient Weight: 77 KG