MAUDE Adverse Event Report: CAREFUSION, INC DEBAKEY CLAMP 25MM JAW 5MM 36CM RATCHET; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	SP90-6343
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Initial emdr.A device is anticipated for investigation.Once the investigation has been completed a supplemental emdr will be submitted for the investigation results.If any additional information is received a supplemental will be submitted with those details.
Event or Problem Description
Grasper stopped working correctly during a case and it was later observed that the screw broke off of the device.It was removed and a new device was used to complete the procedure.X-ray showed that a piece of the screw was still inside the patient's abdomen and would need to be surgically removed after the patient recovered.
Additional Manufacturer Narrative
(b)(4).Supplemental emdr.There was no sample or photo available to bd for evaluation.Therefore, bd was unable to perform a thorough investigation to verify the reported issue.Since, an investigation could not be performed bd was unable to determine a possible root cause.The manufacturing facility has been notified of this incident and the findings.A review of the device history record could not be performed as the reported lot was unknown.If a sample does become available at a later date a supplemental emdr will be submitted with the investigation results.H3 other text: sample was not available for evaluation.
Event or Problem Description
Grasper stopped working correctly during a case and it was later observed that the screw broke off of the device.It was removed and a new device was used to complete the procedure.X-ray showed that a piece of the screw was still inside the patient's abdomen and would need to be surgically removed after the patient recovered.

• Brand Name: DEBAKEY CLAMP 25MM JAW 5MM 36CM RATCHET
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• MDR Report Key: 11762838
• Report Number: 1423507-2021-00030
• Device Sequence Number: 3464300
• Product Code: GEI
• UDI-Device Identifier: 10885403159268
• UDI-Public: (01)10885403159268
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K930666
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/10/2021

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 Model Number: SP90-6343
• Device Catalogue Number: SP90-6343
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 05/03/2021
• Supplement Report FDA Received Date: 06/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other