MAUDE Adverse Event Report: KARL STORZ SE & CO. KG 'KOH' ULTRAMICRO NEEDLE HOLDER, 30 CM; PEDIATRIC NEEDLE HOLDER

Model Number	26167FN
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device has not been returned by the user facility for evaluation.
Event or Problem Description
As per a vigilance report filed with the (b)(6) by the factory in (b)(4), one of our pediatric needle holders failed during use; the triangular grip on one of the jaws of the needle holder came off and an x-ray confirmed by it was in the child.It is unknown at this time if the piece has been removed.
Additional Manufacturer Narrative
The device in question was returned to manufacturing in germany for investigation on 14.09.2020.Upon examination it could be confirmed that the triangular grip on the jaws of the needle holder was broken off in both sides.There are signs of mechanical damage such as dent, fracture on broken pieces and at the broken area.No indication for a material or manufacturing related issue was found during the investigation.The potential root cause is mechanical overload that leads to the breakage.

• Brand Name: 'KOH' ULTRAMICRO NEEDLE HOLDER, 30 CM
• Common Device Name: PEDIATRIC 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 ; 2188201
• MDR Report Key: 9781618
• Report Number: 9610617-2020-00032
• Device Sequence Number: 16882040
• Product Code: GCJ
• UDI-Device Identifier: 04048551095348
• UDI-Public: 4048551095348
• 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: 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: 26167FN
• Device Catalogue Number: 26167FN
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2020
• Supplement Date Received by Manufacturer: 02/12/2020
• Initial Report FDA Received Date: 03/03/2020
• 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: Other
• Patient Sex: Unknown