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U.S. Department of Health and Human Services

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

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US SURGICAL PUERTO RICO MULTIFIRE VERSATACK LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 174023
Device Problems Misfire (2532); Human-Device Interface Problem (2949); Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/10/2017
Event Type  Malfunction  
Event Description

According to the reporter, during a hernia repair, the stapler jammed. Initially fired but later the surgeon was not able to squeeze the handle and it stopped firing. The device was difficult to unload. No patient injury noted. No patient suffered from a blood loss or tissue damage. (b)(4). According to the reporter, on the (b)(6) 2017, during a hernia repair, the stapler jammed. No patient was injured, no patient sufferent blood loss or tissue damage and no surgery had extended or time due to damaged stapler.

 
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Brand NameMULTIFIRE VERSATACK
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
sharon murphy
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key6912086
MDR Text Key88136385
Report Number2647580-2017-06982
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK912097
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 09/06/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/03/2017
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number174023
Device Catalogue Number174023
Device LOT NumberP7C0534X
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/06/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/13/2017
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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