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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 174213
Device Problem Break (1069)
Patient Problem No Patient Involvement (2645)
Event Date 07/15/2019
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 use, part of the jaw was broken. There is no patient involved in this event.

 
Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device. The visual inspection of the returned product noted the jaw of the device was broken at the fulcrum. Pmv performed functional testing and the jaw rotated without difficulty. Other functions of device could not be tested due to condition of device. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. The root cause of the observed damage was due to the product not being used as intended which caused or contributed to the reported condition. Replication of the broken jaw may occur when the device is exposed to a side force (leverage) that consequently breaks one side of the jaws. Another possibility is when the device is activated with too much force to the jaws and is used in a twisting motion resulting in breakage. 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 Key8850743
MDR Text Key152935805
Report Number2647580-2019-03949
Device Sequence Number1
Product Code GET
Combination Product (Y/N)N
Reporter Country CodeKS
PMA/PMN NumberK914753
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 09/11/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/01/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number174213
Device Catalogue Number174213
Device LOT NumberP8C1025X
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/07/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/06/2018
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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