MAUDE Adverse Event Report: KARL STORZ SE & CO. KG MACRO-NEEDLEHOLDER, 5 MM, 33 CM; REUSABLE NEEDLE HOLDER

Model Number	26173KL
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/20/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during surgery, a small metal piece is dislocated from the needle holder.This fragment ended up in the patient's abdomen.There is no information the fragment in question could be retrieved.Internal reference number: (b)(4).
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.
Additional Manufacturer Narrative
During surgery, a small metal piece is dislocated from the needle holder.This fragment ended up in the patient's abdomen.There is no information the fragment in question could be retrieved.Upon evaluation of the instrument, it could be confirmed that it was bent.In addition, the carbide insert is detached.The most probable root cause is improper handling.Further evidence for this probable root cause is a video provided to us by the hospital.This video shows that the needle was bent straight at the end of the sewing process using two needle holders.After consultation, this is not the correct procedure, but the needle is removed through the trocar in its original state.Bending/rotating the needle holders exerts forces on the inserts, which caused the reported malfunction.In conclusion, the failure could be confirmed, but a manufacturing error can be excluded.The customer will be informed about the evaluation results in a separate letter.Internal karl storz reference number: (b)(4).

• Brand Name: MACRO-NEEDLEHOLDER, 5 MM, 33 CM
• Common Device Name: REUSABLE 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 90245-5017 ; 4242188738
• MDR Report Key: 15675196
• Report Number: 9610617-2022-00293
• Device Sequence Number: 6372761
• Product Code: GCJ
• UDI-Device Identifier: 04048551001110
• UDI-Public: 4048551001110
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 26173KL
• Device Catalogue Number: 26173KL
• Device Lot Number: XQ11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2022
• Supplement Date Received by Manufacturer: 11/10/2022
• Initial Report FDA Received Date: 10/26/2022
• Supplement Report FDA Received Date: 11/17/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2019
• 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): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown