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

Catalog Number SP8302

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/16/2023

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 322753214
• Report Number: 1423507-2023-00100
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10885403184154
• UDI-Public: (01)10885403184154
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2023,01/03/2024

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
• Device Operator: 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
• Initial Date Manufacturer Received: 08/16/2023
• Initial Date FDA Received: 09/06/2023
• Supplement Dates Manufacturer Received: 08/16/2023
• Supplement Dates FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention