MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON VERSAPORT BLADELESS OPT 12 CAN; DISPOSABLE SURGICAL ACCESS DEVICE

Model Number ONBFCA12ST

Device Problems Air Leak (1008); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/27/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Procedure: lap gastric bypass.According to the reporter: seal tore and leaked air in lgb.The difficulty did not result in any tissue damage or patient injury.There was no unanticipated tissue loss.The incision was not extended by more than one inch.There was no unanticipated blood loss of 500cc or more.Surgery time was not delayed by more than 30 minutes.No device fragment fell into the patient.

• Brand Name: VERSAPORT BLADELESS OPT 12 CAN
• Type of Device: DISPOSABLE SURGICAL ACCESS DEVICE
• 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: 4991088
• MDR Text Key: 23918529
• Report Number: 1219930-2015-00724
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Report Date: 07/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: ONBFCA12ST
• Device Catalogue Number: ONBFCA12ST
• Device Lot Number: N5F0097X
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1