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

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).

• Brand Name: +IO- 5MM GUARD TROCR(KIT2 SLV)65MM W/GAS
• Type of Device: DISPOSABLE 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 Key: 4652889
• MDR Text Key: 5601155
• Report Number: 9612501-2015-00195
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (Y/N): N
• Reporter Country Code: HK
• PMA/PMN Number: K981941
• Number of Events Reported: 1
• 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 Received: 04/02/2015
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 07/31/2019
• Device MODEL Number: 4216
• Device Catalogue Number: 4216
• Device LOT Number: J4G1487X
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 04/21/2015
• Is The Reporter A Health Professional?: No
• Date Manufacturer Received: 04/02/2015
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 07/26/2014
• Is The Device Single Use?: Yes
• Type of Device Usage: Unkown