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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL SCIS POTTS-SMITH 130 DEG 7.0"; INSTRUMENTS, SURGICAL, CARDIOV
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TELEFLEX MEDICAL SCIS POTTS-SMITH 130 DEG 7.0"; INSTRUMENTS, SURGICAL, CARDIOV Back to Search Results
Catalog Number 640216
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/01/2019
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 scissors broke while being used during surgery per information given by hospital.Additional information indicates the scissors broke at the tip.The patient's condition was reported as fine.
 
Manufacturer Narrative
(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 640216.(1) sample of 640216 lot e7 was received for evaluation.Visual review noted that one of the scissor tips has broken off and the remaining blade is bent towards the missing blade.The device appears to have experienced a striking impact consistent with being dropped.Device damage is the result of a striking impact akin to being dropped.The remaining scissor blade is bent out of alignment supporting this conclusion.(1) sample of 640216 lot e7 was received for evaluation.Visual review noted that one of the scissor tips has broken off and the remaining blade is bent towards the missing blade.The device appears to have experienced a striking impact consistent with being dropped.A dimensional inspection was not required as part of this investigation.The device is not functional in current state and cannot be repaired.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 640216.Device damage is the result of a striking impact akin to being dropped.The remaining scissor blade is bent out of alignment supporting this conclusion.
 
Event Description
It was reported that scissors broke while being used during surgery per information given by hospital.Additional information indicates the scissors broke at the tip.The patient's condition was reported as fine.
 
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Brand Name
SCIS POTTS-SMITH 130 DEG 7.0"
Type of Device
INSTRUMENTS, SURGICAL, CARDIOV
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key9897108
MDR Text Key189623065
Report Number3011137372-2020-00098
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 foreign,health professional
Type of Report Initial,Followup
Report Date 03/27/2020
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
Device Operator Health Professional
Device Catalogue Number640216
Device Lot Number830 E7
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/10/2020
Initial Date Manufacturer Received 03/27/2020
Initial Date FDA Received03/30/2020
Supplement Dates Manufacturer Received08/31/2020
Supplement Dates FDA Received09/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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