MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ULTRAMICRO NEEDLE HOLDER

Model Number	26167FNS
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation on-going.Product currently will stay at the facility.Should the product be sent in later with additional information/investigation results a supplemental medwatch will be submitted unsolicited.The event is filed under internal karl storz complaint id (b)(4).As of today, no other similar case has been found.The manufacture continues to review and investigate.
Event or Problem Description
It was reported that there was event with a 26167fns ultramicro needle holder.According to the information received, part of the needle holder broke off into the patient and needed to be retrieved.No patient harm noted at time of this report.
Additional Manufacturer Narrative
Per the investigation product report the product was not returned.According to the customer's description of the fault, the carbide plate in the jaw section has probably detached.The reason for this is probably excessive force on the jaw or the carbide insert.Since the product was not sent in for examination, no in-depth examination can be carried out.The ifu, points out in warning for risk of injury to patient "overloading the instrument as a result of applying or exerting too much force on it may cause the medical device to break, bend or malfunction".The event is filed under internal karl storz complaint id (b)(4).

• Brand Name: ULTRAMICRO NEEDLE HOLDER
• Common Device Name: NEEDLE HOLDER
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm, ; GM
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 16894483
• Report Number: 9610617-2023-00091
• Device Sequence Number: 6162793
• Product Code: GCJ
• UDI-Device Identifier: 04048551095362
• UDI-Public: 4048551095362
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K951625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2023

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
• Operator of Device: Health Professional
• Device Model Number: 26167FNS
• Device Catalogue Number: 26167FNS
• Device Lot Number: WO01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2023
• Supplement Date Received by Manufacturer: 04/11/2023
• Initial Report FDA Received Date: 05/09/2023
• Supplement Report FDA Received Date: 10/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female