MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON BLADELESS VP 15MM ST W/ FIXATION; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number NB15STF

Device Problem Detachment Of Device Component (1104)

Patient Problems Hemorrhage/Bleeding (1888); Tissue Damage (2104)

Event Date 06/16/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

According to the reporter, during a sleeve gastrectomy the seal from the 15 mm trocar fell into the patient during instrument exchange.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.The seal on the reducer cap came of and went down the trocar and into the patient.The surgeon pulled it out when they noticed it was in there.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Original ftr entered under (b)(4) and emdr submitted with incorrect manufacturing site.New ftr created per mdr procedure in order to populate emdr with correct manufacturing registration number.Original initial report number 1219930-2015-00805 under (b)(4).New report number 9612501-2015-00563 under (b)(4).

• Brand Name: BLADELESS VP 15MM ST W/ FIXATION
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 5075521
• MDR Text Key: 26127478
• Report Number: 1219930-2015-00805
• 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
• Report Date: 06/17/2015

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 Model Number: NB15STF
• Device Catalogue Number: NB15STF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2015
• 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