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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN +IO- 5MM GUARD TROCR(KIT2 SLV)65MM W/GAS DISPOSABLE SURGICAL ACCESS DEVICE

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COVIDIEN +IO- 5MM GUARD TROCR(KIT2 SLV)65MM W/GAS DISPOSABLE SURGICAL ACCESS DEVICE Back to Search Results
Model Number 4216
Device Problems Obturator (488); Valve(s) (527); Detachment Of Device Component (1104); Loose or Intermittent Connection (1371)
Patient Problem No Patient Involvement (2645)
Event Date 04/02/2015
Event Type  Malfunction  
Event Description

Procedure: lap herniorrhaphy. According to the reporter: when the 4216 is opened for use. It is found that that when the obturator is pull out from the cannula, the valve is lossen and pulled out from the head of the cannula. A new set of 4216 was used. No patient involved.

 
Manufacturer Narrative

(b)(4). Initial report sent to fda on 04/02/2015.

 
Manufacturer Narrative

(b)(4).

 
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Brand Name+IO- 5MM GUARD TROCR(KIT2 SLV)65MM W/GAS
Type of DeviceDISPOSABLE SURGICAL ACCESS DEVICE
Manufacturer (Section D)
COVIDIEN
zona franca de san isidro
carretara san isidro km17
santo domingo
DR
Manufacturer (Section G)
COVIDIEN
zona franca de san isidro
carretara san isidro km17
santo domingo
DR
Manufacturer Contact
sharon murphy
60 middletown ave
north haven, CT 06473
2034925267
MDR Report Key4652889
MDR Text Key5601155
Report Number9612501-2015-00195
Device Sequence Number1
Product Code GCJ
Combination Product (Y/N)N
Reporter Country CodeHK
PMA/PMN NumberK981941
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 04/02/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/02/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2019
Device MODEL Number4216
Device Catalogue Number4216
Device LOT NumberJ4G1487X
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/21/2015
Is The Reporter A Health Professional? No
Date Manufacturer Received04/02/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured07/26/2014
Is The Device Single Use? Yes
Type of Device Usage Unkown

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