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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX VISISTAT 35R 6/BOX; STAPLER
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TELEFLEX VISISTAT 35R 6/BOX; STAPLER Back to Search Results
Catalog Number 528135
Device Problems Failure To Adhere Or Bond (1031); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/17/2014
Event Type  malfunction  
Event Description
Alleged event: during a spay/neuter, the stapler was not attaching the staples to the skin properly.Those staples were difficult to remove.There was no consequence to the animal.
 
Manufacturer Narrative
The device history report review (dhr) indicates that the product visistat 35r 6/box, lot # 01k1300063 was manufactured on 10/02/2013 a total of (b)(4) pieces.Lot was released on 10/10/2013.Dhr investigation did not show issues related to complaint.The device sample was received by the mfr and the investigation is pending.The mfr will continue to monitor and trend related complaints.
 
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Brand Name
VISISTAT 35R 6/BOX
Type of Device
STAPLER
Manufacturer (Section D)
TELEFLEX
tecate, b.c.
MX 
Manufacturer Contact
effie jefferson, rn
po box 12600
durham, NC 27709
9194332672
MDR Report Key4001271
MDR Text Key4712970
Report Number3003898360-2014-00456
Device Sequence Number1
Product Code GAG
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 06/26/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator Other
Device Catalogue Number528135
Device Lot Number01K1300063
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/01/2014
Date Manufacturer Received06/26/2014
Date Device Manufactured10/01/2013
Is the Device Single Use? Yes
Patient Sequence Number1
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