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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN LP LLC NORTH HAVEN SIGNIA; STAPLE, IMPLANTABLE
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COVIDIEN LP LLC NORTH HAVEN SIGNIA; STAPLE, IMPLANTABLE Back to Search Results
Model Number SIGPHANDLE
Device Problems Use of Device Problem (1670); Calibration Problem (2890); Human-Device Interface Problem (2949); Noise, Audible (3273)
Patient Problem No Patient Involvement (2645)
Event Date 07/05/2018
Event Type  malfunction  
Manufacturer Narrative
Occupation: other (na).If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, while performing a demo of the device, after fully articulating a reload, the handle was unable to de-articulate.After failed attempts to separate and reconnect the adapter to address the issue, a manual retraction tool was used to successfully straighten and unload the reload.Prior to using the manual retraction tool, the handle would make a low pitch bogging sound when attempting to calibrate both this standard adapter and another short adapter.The handle was then rebooted by depressing both safety buttons and functions as expected with this reported adapter as well as another short adapter.No patient involvement.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
SIGNIA
Type of Device
STAPLE, IMPLANTABLE
Manufacturer (Section D)
COVIDIEN LP LLC NORTH HAVEN
195 mcdermott rd
north haven CT 06473
MDR Report Key7707727
MDR Text Key114845823
Report Number1219930-2018-03957
Device Sequence Number1
Product Code GDW
Combination Product (y/n)N
PMA/PMN Number
K160176
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberSIGPHANDLE
Device Catalogue NumberSIGPHANDLE
Was Device Available for Evaluation? No
Date Manufacturer Received08/08/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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