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

Model Number	26173KL
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2024
Type of Reportable Event	Serious Injury
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 the needle holder broke in the patient's abdomen.Despite x-ray checks the small metal part could not be located.
Additional Manufacturer Narrative
The claimed item 26173kl with the lot op05 was not sent back for examination.Therefore, the complaint and investigation can only be carried out on the basis of the information provided.As can be seen on the provided pictures, the pull rod has broken out of the movable jaw part, which means that the needle holder no longer functions properly.The pull rod and the axle pin have become detached from the jaw section.According to the provided pictures a break can be seen, through which a piece has come loose.This defect shows that a high mechanical force was applied which has probably led to an overload.This can happen, for example, if a part that is too large is clamped in the needle holder, resulting in a higher force acting on the jaw part and drawbar when the jaw part is closed.Another indication of excessive force development is the slightly distorted / bent drawbar.This could no longer absorb the forces when the force was developed.Based on this, we assume use error to be the root cause for the reported issue.The ifu :96116348df v 2.0-10-2017 refers to the excessive force as well as the correct needle.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: MACRO NEEDLE HOLDER
• Common Device Name: SUTURING 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: 19128236
• Report Number: 9610617-2024-00109
• Device Sequence Number: 8359091
• Product Code: GCJ
• UDI-Device Identifier: 04048551001110
• UDI-Public: 4048551001110
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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): 06/14/2024

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: OP05
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 04/17/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2020
• 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