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 Code	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.

• 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
• MDR Report Key: 19154497
• Report Number: 2020550-2024-00115
• Device Sequence Number: 12721195
• Product Code: GCJ
• UDI-Device Identifier: 04048551095362
• UDI-Public: 4048551095362
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/22/2024
• Report Date (Section F): 04/22/2024

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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/18/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/22/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/22/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown