MAUDE Adverse Event Report: KARL STORZ SE & CO. KG SCISSORS, 5 FR., 40 CM

Model Number	26160EHW
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
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 hysteroscopy, a portion of the tip dislodged during the procedure.No patient injury was reported.Surgeon was able to remove the broken piece, and was able to complete the procedure.Per customer, the case date was either (b)(6) 2023 or (b)(6) 2023.
Additional Manufacturer Narrative
Per evaluation findings by the manufacturer: upon examination, it was determined that nothing was broken off and therefore no part flew into the patient.As can be seen in the pictures, the product shows strong corrosion due to a reprocessing error as well as strong dirt in the shaft, therefore the function is difficult.In addition, the cutting edge is probably heavily damaged due to incorrect handling.The device was shipped to the customer under outbound (b)(4) on (b)(6) 2019: had been in use for approximately 3 years and 6 months before this complaint was filed.

• Brand Name: SCISSORS, 5 FR., 40 CM
• Common Device Name: SCISSORS
• 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: 17374757
• Report Number: 9610617-2023-00171
• Device Sequence Number: 15219133
• Product Code: GCJ
• UDI-Device Identifier: 04048551094556
• UDI-Public: 4048551094556
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: 26160EHW
• Device Catalogue Number: 26160EHW
• Device Lot Number: VQ01
• 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: 06/23/2023
• Supplement Date Received by Manufacturer: 06/23/2023
• Initial Report FDA Received Date: 07/21/2023
• Supplement Report FDA Received Date: 09/12/2023
• 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: Female