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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: US SURGICAL PUERTO RICO ENDO DISSECT MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED

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US SURGICAL PUERTO RICO ENDO DISSECT MOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED Back to Search Results
Model Number 176645
Device Problem Failure to Align (2522)
Patient Problem No Patient Involvement (2645)
Event Date 06/05/2018
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

According to the reporter, pre-operatively, the clamps were not aligned in the tip. There was no patient involvement.

 
Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device. Visual inspection and functional testing confirmed there were no abnormalities that would have caused or contributed to the reported condition. A review of the device history record indicates this product was released meeting all quality release specifications at the time of manufacture. The investigation concluded there were no abnormalities that would have caused or contributed to the reported condition. If information is provided in the future, a supplemental report will be issued.

 
Manufacturer Narrative

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

 
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Brand NameENDO DISSECT
Type of DeviceMOTOR, SURGICAL INSTRUMENT, PNEUMATIC POWERED
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 Key7620613
MDR Text Key111740751
Report Number2647580-2018-03020
Device Sequence Number1
Product Code GET
Combination Product (Y/N)N
Reporter Country CodeIT
PMA/PMN NumberK904578
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 11/29/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/20/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number176645
Device Catalogue Number176645
Device LOT NumberP7K1584X
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/20/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/05/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/26/2017
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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