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

Model Number	34310MS-D
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The broken fragment 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 the patient underwent laparoscopic hysterectomy, bilateral salpingo-oophorectomy, and sentinel lymph node staging on (b)(6) 2023.The procedure was uneventful.However, during a surveillance visit with the oncologist in (b)(6) 2024, the patient noted persistent right sided pelvic discomfort since her (b)(6) 2023 surgery.The patient then had an mri on (b)(6) 2024, and a 3mm metallic object was identified in the left pelvis.There was no evidence of recurrent disease.Patient then underwent procedure to remove the fragment on (b)(6) 2024.The removed fragment was examined under dissection scope and appears consistent with surgical scissors that would have been used during laparoscopic procedure back in (b)(6) 2023.

• Brand Name: CLICKLINE SCISSORS INSERT
• Common Device Name: SCISSORS INSERT
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; tuttlingen 78532 ; GM 78532
• MDR Report Key: 19186670
• Report Number: 2020550-2024-00118
• Device Sequence Number: 7403747
• Product Code: GCJ
• UDI-Device Identifier: 04048551336410
• UDI-Public: 4048551336410
• Combination Product (Y/N): N
• 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): 04/25/2024
• Report Date (Section F): 04/25/2024

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: 34310MS-D
• Device Catalogue Number: 34310MS-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/02/2024
• Event Location: Hospital
• Date Report to Manufacturer: 04/25/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2024
• 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 Age: 55 YR
• Patient Sex: Female
• Patient Weight: 27 KG