MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ULTRAMICRO NEEDLE HOLDER, SIZE 3 MM

Model Number	26167FNS
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	01/09/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.Internal karl storz reference number: (b)(4).
Event or Problem Description
It was reported that patient had a follow up ct scan recently after a surgery in mid-(b)(6) 2023, and a foreign body was picked up on the scan.The patient came in for surgery on friday (b)(6) to have the foreign body removed which was successful and it looks to be part of a needle holder.At the time of initial surgery, the broken part was not noticed.No negative impact in state of health reported.The event caused additional surgical intervention to remove broken piece from the patient.
Additional Manufacturer Narrative
During investigation of the returned product it was found that the surface of the tungsten carbide plate is quite closed, no teeth are recognizable.This is an indication that the item has been heavily used.It is therefore important to check the item for damage and function before each use.Due to the wear on the carbide plate, the necessary thickness of the plate may be missing, which leads to it giving way when the needle is clamped and the resulting pressure causes it to break.Internal karl storz reference number: (b)(4).

• Brand Name: ULTRAMICRO NEEDLE HOLDER, SIZE 3 MM
• Common Device Name: ULTRAMICRO NEEDLE HOLDER
• 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: 19154498
• Report Number: 9610617-2024-00115
• Device Sequence Number: 7833875
• Product Code: GCJ
• UDI-Device Identifier: 04048551095362
• UDI-Public: 4048551095362
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26167FNS
• Device Catalogue Number: 26167FNS
• 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: 04/11/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 05/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown