MAUDE Adverse Event Report: KARL STORZ SE & CO. KG COAGULATION & DISSECTION ELECTRODE

Model Number 37370DL

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 10/09/2020

Event Type  Injury  

Manufacturer Narrative

Belated evaluation and reporting of this complaint was done during retrospective review as part of capa: 20-0074 corrective action 6.The device was exerted too much force cause it to bend then break.The damage of the product is not caused by a production problem or material defect.Investigation revealed that the distal tip was broken off and the tip was heavily bent.No signs of corrosion were found at the broken area of the affected device.The event is filed under internal karl storz complaint id: (b)(4).

Event Description

The l-hook tip broken and dropped off in patient body during procedure.

• Brand Name: COAGULATION & DISSECTION ELECTRODE
• Type of Device: COAGULATION & DISSECTION ELECTRODE
• 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: 17127379
• MDR Text Key: 317210872
• Report Number: 9610617-2023-00887
• Device Sequence Number: 1
• Product Code: KNF
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K944862
• 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: 06/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37370DL
• Device Catalogue Number: 37370DL
• Device Lot Number: UR01 / QO02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other