MAUDE Adverse Event Report: CAREFUSION, INC SCISSORS INSERT, MINI METZ, 36CM, 10/BOX; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	SP8302
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr # (b)(4).28aug2023 writer sent the customer an email acknowledging receipt of the complaint and requested follow up information including as to if there was any patient impact related to this event.Writer provided contact information.Device not yet evaluated, if the device is evaluated a follow up will be sent.H3 other text : see h10.
Event or Problem Description
Mat# sp8302, lot # 76722.Mini shear broke during a case today, they were able to retrieve the broken piece and is taped to the mini shear to be sent in.No further information is not available.
Additional Manufacturer Narrative
The device was returned for evaluation and found that the blade had fractured resulting in the reported event.There was no evidence of any degradation to the blade.Hardness and density testing did not reveal any differences between the broken blade and control sample.Retains from grinding were reviewed and no obvious defects were noted.The supplier reviewed the processes and documentation for the notified lot and found no abnormalities.In addition, the third-party raw material supplier was notified of the complaint and reviewed their relevant process and documentation, and no abnormalities were found.Based on the evaluation results, a specific root cause could not be determined.The observed fracture may have been caused by excessive bending forces.It is not expected that the device would experience excessive force as the blades are used for cutting soft tissue for laparoscopic surgery and this is a single use device.Steris will continue to monitor for similar events to ensure the product performs as expected.No additional issues have been reported.
Event or Problem Description
Mat# sp8302, lot # 76722.Mini shear broke during a case today, they were able to retrieve the broken piece and is taped to the mini shear to be sent in.No further information is not available.

• Brand Name: SCISSORS INSERT, MINI METZ, 36CM, 10/BOX
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer (Section G): CAREFUSION, INC; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: anna wehrheim ; 75 north fairway drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 17692769
• Report Number: 1423507-2023-00099
• Device Sequence Number: 20461104
• Product Code: GEI
• UDI-Device Identifier: 10885403184154
• UDI-Public: (01)10885403184154
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K113407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2024
• Report Date (Section F): 09/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: SP8302
• Device Lot Number: 76722
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 09/06/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2023
• Supplement Date Received by Manufacturer: 08/25/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 02/12/2024
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown