MAUDE Adverse Event Report: KARL STORZ SE & CO. KG STAMMBERGER RHINOFORCE II ANTRUM PUNCH

Model Number 459010

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Per the manufacturer's evaluation: the forceps was disassembled and the slider inside was found broken at the rivet eye.The broken surface shows a fresh ductile break; a part of the slide is missing.The cutting area shows at least on indication for a cut trial of something solid--the cutting edges are not sharp anymore.The ductile appearance indicates a break by overload.During the operation in which the device failed, or in a previous one, there has been a try to cut something rigid--the cutting edge is blunt on several spots.The breakage was most likely due to mechanical overload by trying to cut hard tissue (bones); it is for cartilage only.

Event Description

As per report received from the factory in (b)(6) regarding an event in (b)(6): during a paranasal sinuses procedure, the forceps lever got blocked all of a sudden.A small metal particle came loose.It was not possible to open or close the forceps anymore.The particle was retrieved.

• Brand Name: STAMMBERGER RHINOFORCE II ANTRUM PUNCH
• Type of Device: ANTRUM PUNCH
• 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 ; 2188201
• MDR Report Key: 10092940
• MDR Text Key: 199671799
• Report Number: 9610617-2020-00060
• Device Sequence Number: 1
• Product Code: LRC
• UDI-Device Identifier: 04048551164532
• UDI-Public: 04048551164532
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 459010
• Device Catalogue Number: 459010
• Device Lot Number: TT07
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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): Other