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

Model Number	26173KAR
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was evaluated by the manufacturer, karl storz in (b)(4).As per the evaluation: upon evaluation the breakage could be confirmed.The broken off jaw was not returned.The remaining jaw is showing clamp marks outside the clamping area.The area around the breakage looks deformed.The breakage surface has a rough appearance and looks, even which indicates a forced fracture.Clamping outside the clamping area can cause high leverage forces on the hinge.The root cause most likely is too high force initiation due to clamping outside the clamping area.No indications for a material or manufacturing related issue were found during the investigation.Warning of overloading the instrument is included in the related ifu.Also, per the ifu, the instrument must be checked before and after every use for damages.
Event or Problem Description
Per a vigilance report received from the factory in (b)(4), allegedly, there was an event that occurred at a healthcare facility in (b)(6).During surgery, the distal part of the needle holder fell apart and remained in the patient's body.The medical team was unable to visually locate the part.During the surgery, an x-ray examination was preformed to find the broken part.The medical team decided to finish the operation.It is still unclear if they found the missing part during the xray.
Additional Manufacturer Narrative
Upon evaluation the breakage could be confirmed.The broken off jaw was not returned.The remaining jaw is showing clamp marks outside the clamping area.The area around the breakage looks deformed.The breakage surface has a rough appearance and looks even which indicates a forced fracture.Clamping outside the clamping area can cause high leverage forces on the hinge.The root cause most likely is too high force initiation due to clamping outside the clamping area.No indications for a material or manufacturing related issue were found during the investigation.

• Brand Name: MACRO NEEDLE HOLDER
• Common Device Name: NEEDLE HOLDER
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 9634509
• Report Number: 9610617-2020-00011
• Device Sequence Number: 2800382
• Product Code: GCJ
• UDI-Device Identifier: 04048551098141
• UDI-Public: 4048551098141
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/09/2022

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: 26173KAR
• Device Catalogue Number: 26173KAR
• Device Lot Number: TT02
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 01/27/2020
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/15/2016
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown