MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CUTTING LOOP, ANGLED, 24 FR; ENDOSCOPIC ELECTROSURGICAL ELECTRODE, MONOPOLAR, REUSABLE

Model Number 27040G

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 04/24/2022

Event Type  malfunction  

Event Description

As per manufacturer incident report #(b)(4) we received from the factory in (b)(6): during patient treatment, one of the sides of the loop broke off.When this happened, the case was delayed for 45 mins.

Manufacturer Narrative

The device was requested for return.The investigation is pending.

Manufacturer Narrative

Upon investigation, it could be confirmed that the cutting loop was bent and broken at the distal end.The most probable root cause is that the item was damaged by mechanical overload.The hospital will be informed in a separate letter that it is mandatory to inspect the device before use.A product related malfunction can be excluded.

• Brand Name: CUTTING LOOP, ANGLED, 24 FR
• Type of Device: ENDOSCOPIC ELECTROSURGICAL ELECTRODE, MONOPOLAR, REUSABLE
• 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
• Manufacturer Contact: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 14852783
• MDR Text Key: 295345530
• Report Number: 9610617-2022-00102
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/12/2022

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
• Device Operator: Health Professional
• Device Model Number: 27040G
• Device Catalogue Number: 27040G
• Device Lot Number: XO12
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/03/2022
• Initial Date FDA Received: 06/29/2022
• Supplement Dates Manufacturer Received: 08/12/2022
• Supplement Dates FDA Received: 08/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1