MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON SILSPORT 12 TEM INDICATION; ANOSCOPE AND ACCESSORIES

Model Number SILSPT12TA

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional attempts to obtain information and the device have been made.A supplemental report will be submitted with new details if they become available.

Event Description

According to the reporter, one of trocars was broken when package was opened.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).Post market vigilance (pmv) led an evaluation one device.The initial visual inspection of the sample by the pmv investigator noted the flexible sils port was not received.The cannula with the luer lock had a disengaged circular seal.Product analysis suggests the product was used in a surgical procedure.It is possible that the separation of the cap from the cannula is the result of rough handling.The product analysis concluded there were no device abnormalities that would have caused or contributed to the reported incident.No enhancements or improvements were generated for the reported condition.Should new information become available, the file will be re-opened and reassessed at that time.

• Brand Name: SILSPORT 12 TEM INDICATION
• Type of Device: ANOSCOPE AND ACCESSORIES
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer (Section G): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 5928907
• MDR Text Key: 53941249
• Report Number: 1219930-2016-00935
• Device Sequence Number: 1
• Product Code: FER
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103253
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: SILSPT12TA
• Device Catalogue Number: SILSPT12TA
• Device Lot Number: N5H0985X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1