MAUDE Adverse Event Report: COVIDIEN VERPRT PLUS V2 5MM-11MM TRC; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 179095P

Device Problem Break (1069)

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

Event Date 08/04/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Pre-op diagnosis: cholelithiasis anatomy involved: gall bladder.According to the reporter: when using 10mm clip applier, clip applier punched through rubber seal, pushing two small rubber pieces into the abdomen.Current patient status: unknown did the difficulty result in unintended colostomy, formal laparotomy, re-operation etc: no 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 or component was left in the patient.Removed with grasper piece by piece.Post-op diagnosis: same as pre-op.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one device opened by the account.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends and an evaluation of the returned device.The circular seal was damaged.The unit failed an air leak test.The returned sample as received was not found to meet specifications and due to the received damaged seal, the reported condition was confirmed.A review of the device history record indicates this device lot number was released meeting all medtronic quality release specifications at the time of manufacture.Subsequently, the complaint data did not display an increased trend.There were no adverse patient events reported as a result of the alleged event.Should new information become available, the file will be re-opened and reassessed at that time.(b)(4).

• Brand Name: VERPRT PLUS V2 5MM-11MM TRC
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• 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: 4992099
• MDR Text Key: 23991803
• Report Number: 9612501-2015-00471
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K952977
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Model Number: 179095P
• Device Catalogue Number: 179095P
• Device Lot Number: J5C2329X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 37 YR