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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 174027
Device Problems Display or Visual Feedback Problem (1184); Failure to Form Staple (2579)
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, when the device was used to close the mesenteric defect during a laparoscopic gastric bypass, the staple came out without correctly folding and the two staples were fired at the same time causing it to jam. A reload was also fired and this problem occluded again. Another device was used to complete the case. There was no patient injury.

 
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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 Key9908338
MDR Text Key185958790
Report Number2647580-2020-01156
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
Remedial Action Recall
Type of Report Initial,Followup
Report Date 07/27/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/31/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number174027
Device Catalogue Number174027
Device LOT NumberP9J0517Y
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/20/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/16/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/11/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberR202003-06

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