MAUDE Adverse Event Report: CAREFUSION, INC SWITCH-BLADE CURVED METZENBAUM SCISSOR TIP 6 PER CARTON; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	89-5100B
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) initial emdr.End user reported that no device was available for investigation.Therefore, bd was unable to perform a thorough investigation to determine the root cause for the reported failure.A lot/batch number was provided and no issues were found during production.It was reported that the patient was stable but the procedure was delayed.If any additional information becomes available or if the device becomes available for investigation a follow up emdr will be submitted.Date of event was unknown.Bd awareness date was used.
Event or Problem Description
It was reported that the scissor tip disengaged from the handle and fell into the patient during a procedure causing the surgeon to have to open up the patient.It was during a lap chole procedure.The tip was retrieved laparoscopically during a fluoroscopy.The patient was reported to be stable but there was a delay to the procedure.The procedure was completed as planned.

• Brand Name: SWITCH-BLADE CURVED METZENBAUM SCISSOR TIP 6 PER CARTON
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): CAREFUSION, INC; 5 sunnen drive; st. louis MO 63143
• MDR Report Key: 10705636
• Report Number: 1423507-2020-00049
• Device Sequence Number: 17008701
• Product Code: GEI
• UDI-Device Identifier: 10885403278617
• UDI-Public: (01)10885403278617
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K030890
• 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
• Report Date (Section B): 10/16/2020

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: 89-5100B
• Device Catalogue Number: 89-5100B
• Device Lot Number: E19
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2020
• Initial Report FDA Received Date: 10/20/2020
• 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