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

Model Number 27050D

Device Problem Overheating of Device (1437)

Patient Problem Superficial (First Degree) Burn (2685)

Event Type  malfunction  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa 20-0074 corrective action 6.On the article, a gray-colored adhesive seam could be found.However, according to the manufacturing process of karl storz, this connection should be laser welded.Also, the adhesive on the teflon bushing is untypical.In addition, it can be seen that the karl storz inscription has been taped off and the rest of the swivel nut has a different surface which indicates that they were processed.The push button also shows a slight increase, which does not correspond to the karl storz specification (smooth surface).The work element was repaired/processed by an external service provider due to the above reasons.This does not comply with the specifications.User error.The event is filed under internal karl storz complaint id (b)(4).

Event Description

It was reported that there was event with a 27050d - working element.According to the information received, there was a heat generation at the level of the intermediate part of the insulating gachettte of the resector and strong sensation of burning of the pulp of the index finger and smell of burning in the operating room.Redness in the pulp of the right index finger and sharp pain.Need to put the index finger under cold water.No further information available.

• Brand Name: WORKING ELEMENT
• Type of Device: WORKING ELEMENT
• 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: 17290671
• MDR Text Key: 318948144
• Report Number: 9610617-2023-00832
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K882270
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27050D
• Device Catalogue Number: 27050D
• Device Lot Number: WS12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2017
• 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