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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL MICRO RING TIP FCPS 0.5MM 7"; INSTRUMENTS, SURGICAL, CARDIO
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TELEFLEX MEDICAL MICRO RING TIP FCPS 0.5MM 7"; INSTRUMENTS, SURGICAL, CARDIO Back to Search Results
Catalog Number 357647
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/05/2019
Event Type  malfunction  
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 during surgery, we realized that the alignment of the ring tip jaw is not proper, and the jaws are crossing each other, which is dangerous for patients.There is a serious manufacturing defect in this instrument and is required to be replaced immediately.Encountered prior to use.
 
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).(1) sample of 357647 lot c7 was received for evaluation.The distal tip of one of the rings is bent to the side and is out of alignment.No other visual concerns were noted.The distal tip is very delicate and easily bent out of alignment.Given the age of the device ((b)(6) 2017) - it is likely that this instrument was bent during cleaning or use.A dimensional inspection was not required as part of this investigation.The alignment is not correct in fully closed position.No confirmed complaints were received in this range with the same issue.A 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).The distal tip is very delicate and easily bent out of alignment.Given the age of the device ((b)(6) 2017) - it is likely that this instrument was bent during cleaning or use.
 
Event Description
It was reported that during surgery, we realized that the alignment of the ring tip jaw is not proper, and the jaws are crossing each other, which is dangerous for patients.There is a serious manufacturing defect in this instrument and is required to be replaced immediately.Encountered prior to use.
 
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Brand Name
MICRO RING TIP FCPS 0.5MM 7"
Type of Device
INSTRUMENTS, SURGICAL, CARDIO
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key8786351
MDR Text Key150985618
Report Number3011137372-2019-00228
Device Sequence Number1
Product Code DWS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/21/2019
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 Catalogue Number357647
Device Lot NumberC7
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2019
Initial Date Manufacturer Received 06/21/2019
Initial Date FDA Received07/12/2019
Supplement Dates Manufacturer Received08/05/2019
Supplement Dates FDA Received08/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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