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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 Bent (1059); Difficult to Open or Close (2921); Material Twisted/Bent (2981)
Patient Problems Tissue Damage (2104); No Code Available (3191)
Event Date 12/04/2017
Event Type  Malfunction  
Event Description

According to the reporter, during laparoscopic cholecystectomy procedure, the device had curved jaws that caused unwanted tissue cauterizations. Two different devices were opened in the same case, but both the dissector could not be fully closed. Another device was used to complete the procedure. The duration of the anesthesia was extended because of the device replacement, thus extending the surgical time for 30 minutes or more.

 
Manufacturer Narrative

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

 
Event Description

According to the reporter, during laparoscopic cholecystectomy procedure, the device had curved jaws that caused unwanted tissue cauterizations. Two different devices were opened in the same case, but both the dissector could not be fully closed. Another device was used to complete the procedure. The duration of the anesthesia was extended because of the device replacement, thus extending the surgical time for 30 minutes or more. There was a small amount of tissue damage due to the cauterization. Patient is alive.

 
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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
sharon murphy
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key7140871
MDR Text Key95621038
Report Number2647580-2017-09100
Device Sequence Number1
Product Code GET
Combination Product (Y/N)N
Reporter Country CodeTU
PMA/PMN NumberK904578
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/16/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/21/2017
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 NumberP6J0824X
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/18/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/29/2016
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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