MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SCISSORS, 7 FR., 40 CM

Model Number	27178A
Medical Device Problem Codes	Break (1069); Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during a cysto and removal of urolift suture on (b)(6) 2024, a snap was heard and a small crescent shaped piece of the moving part on the scissor broke off.The "surgeon" used the 30* lens, 70* lens and a flexible cystoscope to thoroughly inspect the bladder and urethra.No injury, prolonged case due to looking for foreign body.
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).
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.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
Per investigation by the manufacturing site: as can be seen during product inspection, the cutting edge of the scissors is deformed.It can be assumed that the material was used for a purpose other than the intended one (hard object) and that an attempt was made to cut it.As a consequential failure for the force required for this, the pull rod broke.Therefore, we set the root cause to user error.The age of the article also may have had a negative impact on the material properties of the spring in the handle, which then broke.Age can also have a negative impact on the material properties of the pull rod, leading to fatigue.The ifu points out the intended use of the scissors as well as how to check the condition of the scissors.This event is filed under internal complaint id (b)(4).
Additional Manufacturer Narrative
This report was submitted with the incorrect severity selected on novemeber 5,2024, correction reflected on adverse event, in section b1, b5 and in section h1.This event is filed under internal complaint id (b)(4).
Event or Problem Description
It was reported that the urologist was attempting to cut a suture on a previous urolift implant on (b)(6) 2024.A snap was heard and a small crescent shaped piece of the moving part on the scissor broke off.It was very small and the urologist spent at least an hour inspecting all areas of the bladder and urethra to locate the piece that broke off the flexible scissors.He used the 30* lens, 70* lens and a flexible cystoscope to thoroughly inspect the bladder and urethra.

• Brand Name: SCISSORS, 7 FR., 40 CM
• Common Device Name: SCISSORS, 7 FR., 40 CM
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer (Section G): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen, deu 78532 ,; GM 78532,
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188247
• MDR Report Key: 20611159
• Report Number: 9610617-2024-00434
• Device Sequence Number: 7929203
• Product Code: GCJ
• UDI-Device Identifier: 04048551081419
• UDI-Public: 04048551081419
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K940346
• 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,Followup,Followup
• Report Date (Section B): 01/29/2025

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: 27178A
• Device Catalogue Number: 27178A
• Device Lot Number: MC01
• 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: 10/17/2024
• Supplement Date Received by Manufacturer: 11/14/2024; 01/16/2025; 01/28/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 11/20/2024; 01/23/2025; 01/29/2025
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 90 KG