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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN RELIATACK; STAPLE, IMPLANTABLE
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COVIDIEN LP LLC NORTH HAVEN RELIATACK; STAPLE, IMPLANTABLE Back to Search Results
Model Number RELTACK3X10SW
Medical Device Problem Code Component or Accessory Incompatibility (2897)
Health Effect - Clinical Codes No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event 12/02/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
According to the reporter, during a laparoscopic ventral hernia repair, after firing the device and emptying the first reload.The device was not accepting the new reload.The surgical technician tried to troubleshoot the device, thereby surgical time was extended more than 30 minutes.Another device was used to complete the case.There was no patient injury.
 
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Brand Name
RELIATACK
Common Device Name
STAPLE, IMPLANTABLE
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
MDR Report Key9849155
Report Number1219930-2020-01224
Device Sequence Number14241373
Product Code GDW
UDI-Device Identifier10884521726376
UDI-Public10884521726376
Combination Product (Y/N)N
Initial Reporter StateTX
Initial Reporter CountryUS
PMA/510(K) Number
K140609
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 03/18/2020
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
Operator of Device Health Professional
Device Expiration Date11/30/2021
Device Model NumberRELTACK3X10SW
Device Catalogue NumberRELTACK3X10SW
Device Lot NumberN9C0195Y
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 03/03/2020
Initial Report FDA Received Date03/18/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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