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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 174025
Device Problem Failure to Form Staple (2579)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/27/2020
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

According to the reporter, during a laparoscopy, the stapler was able to fire, the staples had not joined. The staple line was incomplete. A new stapler was opened which had the same lot number to complete the case. There was no patient injury.

 
Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device. Visual inspection of the instrument noted the e-piece was partially disengaged from the device on one side. There was evidence of weld on the device. The single use loading unit (sulu) was received preloaded with four staples remaining. The instrument was applied to the appropriate test media. The handle was actuated and the remaining four tacks deployed improperly and did not seat properly due to the disengaged e-piece. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. Replication of the reported condition may occur as a result of excessive manipulation of the device. The root cause of the observed damage was due to the product not being used as indicated which caused or contributed to the reported condition. No further actions have been deemed necessary at this time. 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 Key9947691
MDR Text Key187180516
Report Number2647580-2020-01300
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeAS
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 05/22/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/10/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number174025
Device Catalogue Number174025
Device LOT NumberP9J1171Y
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/20/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/01/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/25/2019
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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