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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 04/04/2018
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

According to the reporter, during a device follow-up, the device had a quality issue and the dissect clamps are not lining up properly. There was no patient involvement.

 
Manufacturer Narrative

Additional information: evaluation summary: post market vigilance (pmv) led an evaluation of six devices. No abnormalities were found during visual inspection and functional testing of the returned product. Jaw alignment were found to be within specification. A review of the device history record (dhr) indicates the product was released meeting all quality release specifications at the time of manufacture. 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 Key7443082
MDR Text Key105915811
Report Number2647580-2018-01928
Device Sequence Number1
Product Code GET
Combination Product (Y/N)N
Reporter Country CodeSF
PMA/PMN NumberK904578
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/03/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/19/2018
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 NumberP7H1974X
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/23/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/29/2017
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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