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U.S. Department of Health and Human Services

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

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CAREFUSION, INC KAYE-FREEMAN D-SEREDG SCISSR CVD 7IN; INSTRUMENTS, SURGICAL, CARDIOVASCULAR Back to Search Results
Model Number 32-5978
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/06/2021
Event Type  malfunction  
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 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.
 
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 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.
 
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Brand Name
KAYE-FREEMAN D-SEREDG SCISSR CVD 7IN
Type of Device
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 Key12671349
MDR Text Key280060649
Report Number1423507-2021-00046
Device Sequence Number1
Product Code DWS
UDI-Device Identifier10885403148606
UDI-Public(01)10885403148606
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/20/2021,11/12/2021
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
Device Operator Health Professional
Device Model Number32-5978
Device Catalogue Number32-5978
Device Lot NumberXTAZ06
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Hospital
Date Report to Manufacturer10/20/2021
Initial Date Manufacturer Received 10/08/2021
Initial Date FDA Received10/21/2021
Supplement Dates Manufacturer Received10/08/2021
Supplement Dates FDA Received11/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Outcome(s) Other;
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