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	08/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).On 18aug2023, 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.
Event or Problem Description
The complaint is regarding bd item # sp8302, mini metz scissor disposable insert, 5mm, 36cm in which one of the blades broke off into the abdomen of a patient during a laparoscopic cholecystectomy procedure.The broken blade was retrieved from the patient¿s abdomen.Additional information provided was the lot # 77278, expiration date 6.1.2025." no further information is not available.
Additional Manufacturer Narrative
8676067 follow up mdr.Since the product sample or photos are not available, an evaluation could not be performed.The product cannot be investigated properly so the root cause is undetermined.A review of the device history record (dhr) was performed for this lot.There were no issues identified with the material or manufacturing process that would have contributed to the customer's reported issue.The product would have been manufactured and tested according to the specifications.H3 other text : no device available.
Event or Problem Description
The complaint is regarding bd item # sp8302, mini metz scissor disposable insert, 5mm, 36cm in which one of the blades broke off into the abdomen of a patient during a laparoscopic cholecystectomy procedure.The broken blade was retrieved from the patient¿s abdomen.Additional information provided was the lot # 77278, expiration date 6.1.2025." 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: 17692033
• Report Number: 1423507-2023-00100
• Device Sequence Number: 6434912
• Product Code: GEI
• UDI-Device Identifier: 10885403184154
• UDI-Public: (01)10885403184154
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 01/03/2024
• 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: 77278
• 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: 08/16/2023
• Supplement Date Received by Manufacturer: 08/16/2023
• Initial Report FDA Received Date: 09/06/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Required Intervention
• Patient Sex: Unknown