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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 Problems Break (1069); Unintended Movement (3026)
Patient Problem No Patient Involvement (2645)
Event Date 06/25/2020
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

According to the reporter, pre operatively, on a laparoscopic sigmoidectomy, upon taking the product out of the package after opening, the grasping part at the tip was found to be articulated, the black shaft cover nearby was found to be physically damaged. This situation was unlikely from the beginning, but it was unable to see damage from the outside of the package, so that was noticed after opened and took the product out. The procedure was completed with another device. There was no patient involvement.

 
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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 Key10270868
MDR Text Key198715779
Report Number2647580-2020-02151
Device Sequence Number1
Product Code GET
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK904578
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/27/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/14/2020
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 NumberP9D1548PY
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/01/2020
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/11/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/26/2019
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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