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U.S. Department of Health and Human Services

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

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INCISIVE SURGICAL, INC. INSORB SUBCUTICULAR SKIN STAPLER SURGICAL STAPLER Back to Search Results
Model Number 2030
Device Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/25/2016
Event Type  Malfunction  
Event Description

Surgeon went to use device and tip of device cracked while using. This happened a week prior on another case. In both instances a new insorb was opened and used.

 
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Brand NameINSORB SUBCUTICULAR SKIN STAPLER
Type of DeviceSURGICAL STAPLER
Manufacturer (Section D)
INCISIVE SURGICAL, INC.
14405 21st avenue north
plymouth MN 55447
MDR Report Key5503464
MDR Text Key40489327
Report Number5503464
Device Sequence Number0
Product Code GAG
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 03/10/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/16/2016
Is This A Product Problem Report? Yes
Device Operator PHYSICIAN
Device EXPIRATION Date10/01/2017
Device MODEL Number2030
Device Catalogue Number2030
Device LOT Number154301
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/10/2016
Device Age1 dy
Event Location Hospital
Date Report TO Manufacturer03/10/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Type of Device Usage

Patient TREATMENT DATA
Date Received: 03/16/2016 Patient Sequence Number: 1
Treatment
NOT KNOWN.
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