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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 03/05/2020
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

According to the reporter, prior to use, the shaft shell of the two devices had been peeled off. There was no patient involvement.

 
Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device. The visual inspection of the returned product noted that the plastic cable sheath had shearing damage. A functional evaluation found that: jaws of device opened and closed without difficulty. Device rotated without difficulty. Dissecting jaws cut test media without difficulty. Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture. Replication of the reported condition may occur where an excessive force or leverage is applied to the device while retracting the clevis assembly and the clevis boot is subsequently damaged. This subsequent damage may result in improper retraction and deployment of the jaws during articulation and may cause shearing of the plastic cable sheath. 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. No further actions have been deemed necessary at this time. 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 Key9872158
MDR Text Key185262369
Report Number2647580-2020-01057
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 05/15/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/24/2020
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 NumberP8C1154X
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/23/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/01/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/12/2018
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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