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

Model Number 27050E

Device Problems Temperature Problem (3022); Excessive Heating (4030)

Patient Problems Burn(s) (1757); Blister (4537)

Event Date 12/22/2022

Event Type  malfunction  

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 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.

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
• Type of Device: 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
• MDR Text Key: 309974713
• Report Number: 9610617-2023-00032
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 04048551077542
• UDI-Public: 4048551077542
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Weight: 77 KG