MAUDE Adverse Event Report: KARL STORZ SE & CO. KG CLICKLINE INSERT SCISSORS, POINTED

Model Number	28164LBA
Medical Device Problem Codes	Solder Joint Fracture (2324); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device will be forwarded to the manufacturing site for investigation.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted unsolicited.This event is filed under internal complaint id (b)(4).
Event or Problem Description
It was reported that during a right frontal neuro endoscopic arachnoid cyst fenestration on (b)(6) 2024, the scissors broke.They were able to complete the procedure by using a biopsy forcep since they used the scissor for majority of the procedure until it stopped working properly.There was no patient injury reported.Patient had ct scan to ensure scissors did not break inside of the patient, and nothing was found per the ct result.
Additional Manufacturer Narrative
Changes made from the initial report: updated the udi number in section d4.Updated section d9 to yes, and entered the device returned date to the manufacturer.Per investigation by the manufacturing site: during the investigation, it was found that the drawbar was probably torn due to overloading, and the cutting edge also showed clear damage caused by improper use of the scissors.We therefore assume that this was clearly an user error.This event is filed under internal complaint id (b)(4).

• Brand Name: CLICKLINE INSERT SCISSORS, POINTED
• Common Device Name: CLICKLINE INSERT SCISSORS, POINTED
• 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 ; 4242188247
• MDR Report Key: 19524993
• Report Number: 9610617-2024-00166
• Device Sequence Number: 18227058
• Product Code: GWG
• UDI-Device Identifier: 04048551007815
• UDI-Public: 04048551007815
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K021050
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2024

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: 28164LBA
• Device Catalogue Number: 28164LBA
• Device Lot Number: XN06
• 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: 05/17/2024
• Supplement Date Received by Manufacturer: 08/09/2024
• Initial Report FDA Received Date: 06/12/2024
• Supplement Report FDA Received Date: 08/26/2024
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown