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

Model Number	26160SHW
Medical Device Problem Codes	Crack (1135); Material Fragmentation (1261); Pitted (1460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
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
It was reported that fragment was identified in the uterus when viewed on the monitor during the cervical procedure with the 26160shw(zp02).The procedure was delayed to identify and remove the debris; however, the debris was very fine and could not be removed.There has been no impact on the patient so far.
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
The claimed item 26160 shw with the date of manufacture december 2020 was found to be damaged at the distal end.The article has cracks in the material and a notch in the fork.A check of the inspection lot shows that no defects were found during the inspection.The initial stage of pitting and the notch developing into a crack.The piece missing from the notch is less than a millimetre in size, which may indicate that this piece has rusted away due to corrosion (as pitting can be seen at the edges), or it may have come loose during surgery.Therefore, as described in the instructions for use the item should be checked for function and damage before each use.Otherwise, pieces may come loose due to damage or, as in this case, corrosion.Internal karl storz reference number: (b)(4).

• Brand Name: SCISSORS, 5 FR.
• Common Device Name: SCISSORS, 5 FR.
• 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: 17326738
• Report Number: 9610617-2023-00159
• Device Sequence Number: 17733913
• Product Code: GCJ
• UDI-Device Identifier: 04048551094655
• UDI-Public: 4048551094655
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/25/2023

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: 26160SHW
• Device Catalogue Number: 26160SHW
• Device Lot Number: ZP02
• 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: 07/04/2023
• Supplement Date Received by Manufacturer: 07/25/2023; 10/11/2023
• Initial Report FDA Received Date: 07/14/2023
• Supplement Report FDA Received Date: 08/10/2023; 10/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2014
• 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