MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MACRO NEEDLE HOLDER,

Model Number	26173KPL
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
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).
Event or Problem Description
It was reported that there was a broken tie rod.Additional patient information is not available.
Additional Manufacturer Narrative
B5 narrative was corrected to reflect a more accurate depiction of the event that took place.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
Correction: based upon new information received, this event was re-evaluated and is considered no longer reportable - no malfunction or serious injury.

• Brand Name: MACRO NEEDLE HOLDER,
• Common Device Name: MACRO NEEDLE HOLDER,
• 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: anja fair ; 2151 e grand ave; el segundo, CA 90245
• MDR Report Key: 16868422
• Report Number: 9610617-2023-00094
• Device Sequence Number: 5957902
• Product Code: GCJ
• UDI-Device Identifier: 04048551098233
• UDI-Public: 4048551098233
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K951625
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

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: 26173KPL
• Device Catalogue Number: 26173KPL
• Device Lot Number: YN03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 05/04/2023
• Supplement Report FDA Received Date: 06/01/2023
• 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