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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: US SURGICAL PUERTO RICO MULTIFIRE ENDO HERNIA LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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US SURGICAL PUERTO RICO MULTIFIRE ENDO HERNIA LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 174007
Device Problems Display or Visual Feedback Problem (1184); Failure to Form Staple (2579); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/10/2020
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

According to the reporter, on a bariatric gastric bypass, during the closure of the mesenteric defect, the staple came out without folding correctly and two staples were fired at the same time causing it to jam. Another device was used to complete the case. There was no patient injury.

 
Manufacturer Narrative

This report was sent in error as a duplicate for mfr report number: 2647580-2020-01156, any additional information received in the future will be captured and submitted under the report number 2647580-2020-01156. If information is provided in the future, a supplemental report will be issued.

 
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Brand NameMULTIFIRE ENDO HERNIA
Type of DeviceLAPAROSCOPE, GENERAL & PLASTIC SURGERY
Manufacturer (Section D)
US SURGICAL PUERTO RICO
201 sabanetas industrial park
ponce PR 00716 4401
Manufacturer (Section G)
US SURGICAL PUERTO RICO
201 sabanetas industrial park
ponce PR 00716 4401
Manufacturer Contact
lisa hernandez
60 middletown ave.
north haven, CT 06473
2034925563
MDR Report Key9941143
MDR Text Key187745789
Report Number2647580-2020-01282
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK912097
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 05/01/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/08/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number174007
Device Catalogue Number174007
Device LOT NumberP0C1640Y
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/07/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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