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

Model Number	26173KL
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a metal piece came off - during use.A small metal piece came off from the needle holder.No negative impact in state of health reported.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
It was reported that a metal piece came off - during use.A small metal piece came off from the needle holder.No negative impact in state of health reported.
Additional Manufacturer Narrative
Additional information has been provided in section b1, b2, and b5.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
New information received.According to the new information during a laparoscopic hysterectomy, the vaginal septum was sutured and a metal piece approximately 1 mm in size came loose from the tip of the instrument and fell into the patient's abdominal cavity.The loose piece was found and removed, but it is not certain whether other pieces remained in the patient.No negative impact in state of health reported.
Additional Manufacturer Narrative
Result of investigation: during a visual inspection of item 26173kl with batch number lot ym09, it was found that the hole in the pull rod on the movable jaw piece is broken.This may have been caused by excessive force being applied to the material, for example when using a needle that is too large.This ultimately led to the pull rod breaking.The above investigations did not reaveal a root cause related to the labelling, the device or its history.All production related quality checks were passed and no non-conformities were identified in the devices manufacturing records.The labelling was found to contain adequate instructions and warnings.The ifu: 96116348df; version: 2.0 - 10-2017already contains a caution not to overload the instrument as it may cause the medical device to break on page 4.The complaint history did not reveal any pick up in similar complaints, no trend was identified.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: MACRO NEEDLE HOLDER, 5 MM, 33 CM
• Common Device Name: MACRO 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: 21369440
• Report Number: 9610617-2025-00189
• Device Sequence Number: 8435032
• Product Code: GCJ
• UDI-Device Identifier: 04048551001110
• UDI-Public: 04048551001110
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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,Followup
• Report Date (Section B): 10/19/2025

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: YM09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2025
• Supplement Date Received by Manufacturer: 02/13/2025; 08/14/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 02/28/2025; 10/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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