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

Model Number	26167FNS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was discovered one of the gripping tips from the 3mm laparoscopic needle holder was missing.The staff was unsure if it was there at the beginning of the case.The patient has since been x-rayed and it appears the small part of the needle holder is still inside the patient.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: ULTRAMICRO NEEDLE HOLDER, SIZE 3 MM
• Common Device Name: NEEDLE HOLDER REUSABLE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• MDR Report Key: 16380747
• Report Number: 2020550-2023-00043
• Device Sequence Number: 6082283
• 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): 02/15/2023
• Report Date (Section F): 02/13/2023

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
• Device Lot Number: TP02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/13/2023
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/13/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/15/2023
• 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