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

Model Number	26173ML
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received by the factory.
Event or Problem Description
As per a manufacturer incident report we received from the factory in (b)(6): tip of the instrument broke off in the patient during the suturing process.Tip could be digitally palpated, and salvaged by incision expansion.The tip was found under the muscle.
Additional Manufacturer Narrative
The tip of the needle holder has broken off - the broken surfaces are partially discolored, which indicates an earlier damage.The shaft of the instrument is also bent in several directions.The broken tip was not provided.The affected instrument should no longer have been used due to the bending.The instrument was in use for 9 years.The second instrument mentioned shows identical damage, but the tip is bent and not yet broken.

• Brand Name: KOH AXIAL 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: 10597472
• Report Number: 9610617-2020-00103
• Device Sequence Number: 13751052
• Product Code: GCJ
• UDI-Device Identifier: 04048551098455
• UDI-Public: 4048551098455
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• 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: 26173ML
• Device Catalogue Number: 26173ML
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 08/26/2020
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown