MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SCISSORS, BLUNT, 5 FR., 34 CM

Model Number	26159EHW
Medical Device Problem Codes	Crack (1135); Material Fragmentation (1261); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The affected device has been requested for investigation by the manufacturer.Device was not yet returned for investigation.The event is filed under internal karl storz complaint id: (b)(4).
Event or Problem Description
Tiny metal fragments (powder-like) were dislodged from the scissors when it was inserted into the patient's uterus via single-flow operating sheath.One larger fragment attempted to be removed but washed out when trying to transfer to the specimen container.
Additional Manufacturer Narrative
The item in question was returned to the manufacturer.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
Visual and microscopical examination revealed that the cutting surfaces show the usual signs of wear considering their age (manufacturing date - august 2018).A closer inspection of the blades does not reveal any defects.The function of the blades was tested and is given.Since the article is already from 2018, defects / product issues on the cutting blades would have been noticed earlier.It cannot be confirmed that the foreign particles are material from the shears.The ifu refers to the service life of the product and regular testing.The event is filed under internal karl storz complaint id: (b)(4).

• Brand Name: SCISSORS, BLUNT, 5 FR., 34 CM
• Common Device Name: SCISSORS, BLUNT
• 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: 17491417
• Report Number: 9610617-2023-00206
• Device Sequence Number: 15277265
• Product Code: GCJ
• UDI-Device Identifier: 04048551094280
• UDI-Public: 4048551094280
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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
• Report Date (Section B): 11/17/2023

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: 26159EHW
• Device Catalogue Number: 26159EHW
• Device Lot Number: VR01
• 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: 08/01/2023
• Supplement Date Received by Manufacturer: 08/09/2023; 10/20/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 08/22/2023; 11/17/2023
• 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 Sex: Unknown