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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO UNIVERSAL 65; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

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US SURGICAL PUERTO RICO ENDO UNIVERSAL 65; LAPAROSCOPE, GENERAL & PLASTIC SURGERY Back to Search Results
Model Number 173052
Device Problem Mechanical Jam (2983)
Patient Problem No Information (3190)
Event Date 10/01/2020
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 surgical laparoscopy with repair of inguinal hernia, the device jammed while surgeon was using it.Second stapler was opened and used to complete the case.
 
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Brand Name
ENDO UNIVERSAL 65
Type of Device
LAPAROSCOPE, 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 Key10809988
MDR Text Key215314843
Report Number2647580-2020-03767
Device Sequence Number1
Product Code GCJ
UDI-Device Identifier10884521070523
UDI-Public10884521070523
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K912097
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number173052
Device Catalogue Number173052
Device Lot NumberP9L0953Y
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 10/27/2020
Initial Date FDA Received11/09/2020
Date Device Manufactured11/05/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age54 YR
Patient Weight104
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