MAUDE Adverse Event Report: KARL STORZ SE & CO. K CLICKLINE OUTER SHEATH/SCISSORS INSERT

Model Number	30310MWS
Medical Device Problem Codes	Break (1069); Corroded (1131); Material Fragmentation (1261); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unintended Radiation Exposure (4565)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.The 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 during the surgery on a child, the scissors came apart and one of the jaws separated from the instrument.The scissor jaw was retrieved but the lug that holds the jaw to the main instrument was lost.Patient was x rayed by c arm on the table, but no lugs was seen.No negative impact in state of health reported.The procedure could be completed successfully with a delay of less than 15 mins.Since an x-ray was done and the location of the lug is unclear, this case is reportable.
Additional Manufacturer Narrative
This supplemental report is to correct the date of the initial submission of this event.Please see section b4.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The device in question was returned to the manufacturer.This information is reflected in section d9.The evaluation is anticipated, but not yet begun.The investigation will be performed by a designated karl storz employee.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
Technical analysis: during the examination of the claimed item 30310mws with the lot number ty 4, an age of 11 years was determined on the basis of the lot code.This means that the instrument was exposed to several sterilization and disinfection cycles over a long period of use.Defects found: visible contamination and corrosion at the defective and claimed area.A slight discoloration can be seen on the broken rivet, indicating material fatigue.Due to the long-term use of the instrument and the repeated mechanical stress, the rivet was most likely weakened.It is likely that the service life of the instrument was reached after 11 years.Due to the excessive mechanical stress caused by the higher force required, this eventually led to the breakage of the rivet and the loss of the rivet head.The corrosion and wear observed indicate that the instrument may no longer have met the safety standards and should have been discarded.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
This report is to address an error in the year entered in the initial and supplemental reports submitted for this event.The mdr number should be 9610617-2025-00011 and not 9610617-2024-00011.The event is filed under internal karl storz complaint id: (b)(4).
Additional Manufacturer Narrative
The aware date was accidently omitted form the 5th supplemental report for this event.The event is filed under internal karl storz complaint id: (b)(4).This report is to address an error in the year entered in the initial and supplemental reports submitted for this event.The mdr number should be 9610617-2025-00011 and not 9610617-2024-00011.
Additional Manufacturer Narrative
Apologies for the late reporting of this importer.The initial was reported on time but was mistakenly reported as a malfunction.This report is to provide an importer for a report that should have been reported as a serious injury.Corrections are made in section b1 and b2.The event is filed under internal karl storz complaint id: (b)(4).This report is to address an error in the year entered in the initial and supplemental reports submitted for this event.The mdr number should be 9610617-2025-00011 and not 9610617-2024-00011.

• Brand Name: CLICKLINE OUTER SHEATH/SCISSORS INSERT
• Common Device Name: OUTER SHEATH/SCISSORS INSERT
• Manufacturer (Section D): KARL STORZ SE & CO. K; dr.-karl-storz-strasse 34; tuttlingen,
• 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: 21060523
• Report Number: 9610617-2024-00011
• Device Sequence Number: 8153181
• Product Code: GCJ
• UDI-Device Identifier: 04048551121856
• UDI-Public: 04048551121856
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K935071
• 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,Followup,Followup
• Report Date (Section B): 04/15/2025

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: 30310MWS
• Device Catalogue Number: 30310MWS
• Device Lot Number: TY4
• 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: 12/20/2024
• Supplement Date Received by Manufacturer: 01/02/2025; 01/14/2025; 02/21/2025; 04/07/2025; Not provided; 01/02/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 01/02/2025; 01/28/2025; 02/25/2025; 04/07/2025; 04/15/2025; 04/15/2025
• 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: Required Intervention
• Patient Sex: Unknown