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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL MAYO SCISSORS CVD 6 3/4" BEV; SCISSORS, GENERAL, SURGICAL
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TELEFLEX MEDICAL MAYO SCISSORS CVD 6 3/4" BEV; SCISSORS, GENERAL, SURGICAL Back to Search Results
Catalog Number 141317
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/13/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that the surgeon was doing a hip surgery and was cutting near the fascia around ashtabula and the next thing the scissors were in three pieces per the scrub nurse.They then stopped the surgery, did an x-ray, and then general surgery removed the piece still in patient.
 
Event Description
It was reported that the surgeon was doing a hip surgery and was cutting near the fascia around ashtabula and the next thing the scissors were in three pieces per the scrub nurse.They then stopped the surgery, did an x-ray, and then general surgery removed the piece still in patient.
 
Manufacturer Narrative
Qn#(b)(4).Device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to (b)(4).(b)(4) sample of 141317 lot k2 (december of 2012) was received for evaluation.Visual review noted that one of the scissor blades has broken around the midpoint of the blade.Device is (b)(4) years old and has exceeded its effective life.(b)(4) sample of 141317 lot k2 ((b)(6)2012 ) was received for evaluation.Visual review noted that one of the scissor blades has broken around the midpoint of the blade.A dimensional inspection was not required as part of this investigation.A functional inspection was not required as part of this investigation.No confirmed complaints were received in this range with the same issue.Device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to (b)(4).Device is (b)(4) years old and has exceeded its effective life.
 
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Brand Name
MAYO SCISSORS CVD 6 3/4" BEV
Type of Device
SCISSORS, GENERAL, SURGICAL
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key9527067
MDR Text Key173176768
Report Number3011137372-2019-00433
Device Sequence Number1
Product Code LRW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Type of Report Initial,Followup
Report Date 12/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number141317
Device Lot Number830 K2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/17/2020
Initial Date Manufacturer Received 12/18/2019
Initial Date FDA Received12/27/2019
Supplement Dates Manufacturer Received01/27/2020
Supplement Dates FDA Received02/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age74 YR
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