MAUDE Adverse Event Report: CAREFUSION, INC OCHSNER ARTERY FORCEPS, STRAIGHT 1X2 TEETH; FORCEPS, GENERAL & PLASTIC SURGERY

Model Number SU2804

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/28/2022

Event Type  Injury  

Event Description

Customer filed medwatch # (b)(4).Doctor noted the post operative x-ray a metal fragment that was not part of the total joint.The surgical camp was found, and it was missing one of the 3 teeth.The patient decided to undergo another surgery in order to have the metal fragment removed.The complaint sample, photos, lot number, or further information are not available.

Manufacturer Narrative

(b)(4).On (b)(6) 2022, 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.

• Brand Name: OCHSNER ARTERY FORCEPS, STRAIGHT 1X2 TEETH
• Type of Device: FORCEPS, GENERAL & PLASTIC SURGERY
• 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: 14160590
• MDR Text Key: 289689540
• Report Number: 1423507-2022-00010
• Device Sequence Number: 1
• Product Code: GEN
• UDI-Device Identifier: 10885403064609
• UDI-Public: (01)10885403064609
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/20/2022,04/08/2022

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
• Device Operator: Health Professional
• Device Model Number: SU2804
• Device Catalogue Number: SU2804
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/20/2022
• Event Location: Hospital
• Date Report to Manufacturer: 04/20/2022
• Initial Date Manufacturer Received: 04/06/2022
• Initial Date FDA Received: 04/20/2022
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention