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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INCISIVE SURGICAL INC. INSORB SUBCUTICULAR SKIN STAPLER

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INCISIVE SURGICAL INC. INSORB SUBCUTICULAR SKIN STAPLER Back to Search Results
Lot Number 162701
Device Problems Defective Component (2292); Failure to Form Staple (2579); Activation, Positioning or SeparationProblem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/12/2016
Event Type  Malfunction  
Event Description

According to the scrub tech the insorb stapler was working on one side of the staple gun only which prevented it from deploying the staples correctly as the other side of the gun was not working. The defective equipment was changed out to another stapler for the rest of the c-section case.

 
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Brand NameINSORB SUBCUTICULAR SKIN STAPLER
Type of DeviceSTAPLER
Manufacturer (Section D)
INCISIVE SURGICAL INC.
plymouth MN 55447
MDR Report Key6193329
MDR Text Key63103283
Report NumberMW5066822
Device Sequence Number1
Product Code GAG
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 12/19/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/19/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2018
Device LOT Number162701
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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