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

Model Number	26173KAF
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the received information, during a procedure, the joint at the tip of a macro needle holder broke while using in patient body, as reported by user.An x-ray scan was done and found no foreign objects, user did not feedback if any replacement was used.The clamping jaw is now loose as a result.No negative impact in state of health reported.The reported incident involved a device malfunction during use, which prompted postoperative radiographic examination to exclude the presence of retained device fragments.The imaging confirmed that no foreign body remained in the patient, and no injury, deterioration in health, or other clinically harmful outcome was reported.
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.The evaluation is anticipated but not yet begun.The investigation will be performed by a designated karl storz employee.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 ; GM 78532
• Manufacturer (Section G): KARL STORZ SE & Co. KG; dr.-karl-storz-strasse 34; tuttlingen, 78532 ; GM 78532
• Manufacturer Contact: theresa mussaw ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 50850352
• Report Number: 9610617-2026-02216
• Device Sequence Number: 13138682
• Product Code: GCJ
• UDI-Device Identifier: 04048551098097
• UDI-Public: 04048551098097
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K951625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26173KAF
• Device Catalogue Number: 26173KAF
• Device Lot Number: TK03
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown