MAUDE Adverse Event Report: KARL STORZ SE & CO. KG ULTRAMICRO NEEDLE HOLDER, 30 CM; NEEDLE HOLDER, REUSABLE

Model Number	26167FN
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that there was an issue with ultramicro needle holder, 30 cm, during surgery.According to the complaint description a metal fragment was found in situ during surgery.The needle holder was used to suture the colon wall (sigma).After finishing the suture, the presence of a metal fragment on the wall of an intestinal loop was found and it was removed.The consequence was a prolonged surgery time and execution of abdominal x-ray.The surgery was completed successfully and no negative impact on the state of health was reported.
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, 30 CM
• 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: 16599563
• Report Number: 2020550-2023-00066
• Device Sequence Number: 6165227
• Product Code: GCJ
• UDI-Device Identifier: 04048551095348
• UDI-Public: 4048551095348
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 03/23/2023
• Report Date (Section F): 03/22/2023

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: 26167FN
• Device Catalogue Number: 26167FN
• Device Lot Number: DA061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/22/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2023
• 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