MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ROUND KNIFE 45°, Ø 2 MM, 16 CM

Model Number 226820

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/17/2020

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated by the manufacturer, karl storz in (b)(4).As per the evaluation: the round knife is broken off distally and the broken part is missing.Corrosion can be seen on the fracture surface, which indicates pre-damage.Excessive force, such as leveraging, can lead to damage.The knife must be checked tor damage before each use and should have been detected.Furthermore, not too much force should be applied to the knife.

Event Description

Per a vigilance report received from the factory in (b)(4), allegedly, there was an event that occurred at a healthcare facility in (b)(6).The distal end of the instrument, a round knife, broke during the procedure and the procedure was aborted.Customer confirmed that the broken fragment did not remain in the patient.

• Brand Name: ROUND KNIFE 45°, Ø 2 MM, 16 CM
• Type of Device: ROUND KNIFE
• 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: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 9634510
• MDR Text Key: 194178439
• Report Number: 9610617-2020-00010
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 04048551079959
• UDI-Public: 4048551079959
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/24/2020

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: 226820
• Device Catalogue Number: 226820
• Device Lot Number: TS01
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/17/2020
• Initial Date FDA Received: 01/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2005
• 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
• Patient Outcome(s): Required Intervention