MAUDE Adverse Event Report: CAREFUSION, INC KAYE-FREEMAN D-SEREDG SCISSR CVD 7IN; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number	32-5978
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr # (b)(4).12oct2021 writer sent the customer an email acknowledging receipt of the complaint, providing the complaint tracking number 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
Per complaint details received: customer explained that while using our kaye-freeman d-seredg scissr cvd 7in (32-5978) in surgery, a portion of the scissor broke off inside of the patient.They then did an x-ray and could not find the portion that broke off.It still has not been found.No further information available.
Additional Manufacturer Narrative
Follow up (b)(4).The product was returned, and an evaluation was performed on the five-year-old instrument.The root cause of the reported issue is that the instrument has been reworked by an unauthorized 3rd party repair company.A small part of the tc-material broke out.The solder material on the ground material is good.The blade of the broken upper blade has been polished and the cutting edge has been sharpened.There is no serration.It is suspected that the scissor has been damaged during the rework.There have been no issues identified with the material or manufacturing process.The product has been manufactured and tested according to the specifications.A review of the device history records (dhr) did not identify and issues that would have contributed to the reported issue.
Event or Problem Description
Per complaint details received: customer explained that while using our kaye-freeman d-seredg scissr cvd 7in (32-5978) in surgery, a portion of the scissor broke off inside of the patient.They then did an x-ray and could not find the portion that broke off.It still has not been found.12oct2021 additional information: 1.What was the procedure that was being performed? pelvic floor reconstruction.2.Did any part the instrument fall into the patient¿s body, and if so, how was it retrieved? yes, a small portion of a scissor blade broke off from the instrument and the piece was never found.3.What was the patient¿s outcome? patient was stable and unaffected.An x-ray was done, and the piece was not found.4.Was the procedure completed as planned? yes, the procedure was completed as planned.5.Is the instrument available to send back to us for an evaluation? yes, the instrument is available to send back for evaluation.No further information available.

• Brand Name: KAYE-FREEMAN D-SEREDG SCISSR CVD 7IN
• Common Device Name: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• 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: 12671349
• Report Number: 1423507-2021-00046
• Device Sequence Number: 14592727
• Product Code: DWS
• UDI-Device Identifier: 10885403148606
• UDI-Public: (01)10885403148606
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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,Followup
• Report Date (Section B): 11/12/2021
• Report Date (Section F): 10/20/2021

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: 32-5978
• Device Catalogue Number: 32-5978
• Device Lot Number: XTAZ06
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/08/2021
• Supplement Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 10/21/2021
• Supplement Report FDA Received Date: 11/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown