MAUDE Adverse Event Report: CAREFUSION, INC DEBAKEY CLAMP 25MM JAW 5MM 36CM RATCHET; GENERAL & PLASTIC SURGERY

Model Number	SP90-6343
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).(b)(6) 2023 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
Mat# sp90-6343 lot# unknown.Verbatim: the jaw of the grasper broke while being used in surgery.They had to bring x-ray in to ensure nothing fell inside the patient.No further information available.

• Brand Name: DEBAKEY CLAMP 25MM JAW 5MM 36CM RATCHET
• Common Device Name: GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• Manufacturer (Section G): CAREFUSION - ST. LOUIS; 5 sunnen dr; saint louis MO 63143
• Manufacturer Contact: andrew elia ; 5 sunnen dr; saint louis, MO 63143
• MDR Report Key: 17039293
• Report Number: 1923569-2023-00008
• Device Sequence Number: 17745666
• Product Code: GEN
• UDI-Device Identifier: 10885403159268
• UDI-Public: (01)10885403159268
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K930666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/15/2023
• Report Date (Section F): 06/01/2023

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: SP90-6343
• Device Catalogue Number: SP90-6343
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/01/2023
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/11/2023
• Initial Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/01/2023