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

Model Number	28164LBA
Medical Device Problem Code	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	Serious Injury
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.

• 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
• MDR Report Key: 19524992
• Report Number: 2020550-2024-00166
• Device Sequence Number: 18227057
• Product Code: GWG
• UDI-Device Identifier: 04048551007815
• UDI-Public: 4048551007815
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/12/2024
• Report Date (Section F): 06/12/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/17/2024
• Event Location: Hospital
• Date Report to Manufacturer: 06/12/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown