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

Model Number SP90-6343

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/10/2023

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 316318128
• Report Number: 1923569-2023-00008
• Device Sequence Number: 1
• Product Code: GEN
• UDI-Device Identifier: 10885403159268
• UDI-Public: (01)10885403159268
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K930666
• 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: 06/01/2023,05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Report Sent to FDA: 06/01/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/01/2023
• Date Manufacturer Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention