MAUDE Adverse Event Report: KARL STORZ SE & Co. KG Macro Needle Holder, 5 mm, 33 cm

Model Number	26173KAR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported: "during the procedure, the tip of the product in question broke." furthermore, it was reported that: the patient underwent a ct scan, but no damage was found.
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: Macro Needle Holder, 5 mm, 33 cm
• Common Device Name: Macro Needle Holder, 5 mm, 33 cm
• Manufacturer (Section D): KARL STORZ SE & Co. KG; dr.-karl-storz-strasse 34; tuttlingen 78532
• MDR Report Key: 50064048
• Report Number: 50064048
• Device Sequence Number: 10078384
• Product Code: GCJ
• UDI-Device Identifier: 04048551098141
• UDI-Public: 04048551098141
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/28/2026
• Report Date (Section F): 07/28/2026

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: 26173KAR
• Device Catalogue Number: 26173KAR
• Device Lot Number: SK04
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/18/2026
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/29/2026
• 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: Required Intervention
• Patient Sex: Unknown