MAUDE Adverse Event Report: COVIDIEN BLADELESS VP 15MM ST W/ FIXATION; DISPOSABLE SURGICAL ACCESS DEVICE

Model Number NB15STF

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

According to the reporter: the customer pointed out that the white rim seal on the trocar, under the removable top, comes off very easily.They have had a few pop off as they were pulling specimens out.They don't believe it should come off at all.Some areas of the hospital have to count anything that can come off, and they would have to count this seal.No additional information is available from the account.

Manufacturer Narrative

(b)(4).

• Brand Name: BLADELESS VP 15MM ST W/ FIXATION
• 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: 4466426
• MDR Text Key: 5183476
• Report Number: 9612501-2015-00066
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081169
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NB15STF
• Device Catalogue Number: NB15STF
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1