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

Model Number	34310MS-D
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261); Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Insufficient Information (4580); 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 march 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.
Additional Manufacturer Narrative
The returned broken fragment was discarded by accident, and therefore cannot be sent 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 broken fragment could not be returned to the legal manufacturer because the return shipment could not be located by the karl storz logistics center in the us.Therefore, an analysis was performed without the fragment based on the available pictures and information.The reporting facility had provided two pictures, showing the recovered fragment, and a photo of unbroken scissors with an assumed area from which the fragment had broken off.The facility believes that the fragment belongs to item 34310ms-d or 34310ma-d.Based on an analysis of the images and an evaluation of items 34310ms-d and 34310ma-d, the legal manufacturer concludes that this fragment does not belong to one of these devices.First, the grinding pattern does not match.One is transverse and the other grinding pattern is left.Second, the shape of the fragment in this position does not fit because the back of the scissors has a higher thickness (see attached figure 3), which means that a breakout pattern like this is not possible.Third, because it is a cutting instrument, the material is harder and therefore more susceptible to brittleness.This usually leads to a complete breakage of the instrument.Fourth, our records indicate there are no complaints about breakage in the distal area or similar cases.Therefore, the conclusion is that this fragment does not belong to article 34310ms-d or 34310md-d.This event is filed under internal complaint id (b)(4).

• 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
• 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: 19186678
• Report Number: 9610617-2024-00118
• Device Sequence Number: 7431233
• Product Code: GCJ
• UDI-Device Identifier: 04048551336410
• UDI-Public: 4048551336410
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 07/15/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 05/22/2024; 06/19/2024
• Initial Report FDA Received Date: 04/25/2024
• Supplement Report FDA Received Date: 06/13/2024; 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 55 YR
• Patient Sex: Female
• Patient Weight: 27 KG