MAUDE Adverse Event Report: DAVIS & GECK CARIBE LTD VERSAONE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number ONB15STF

Device Problems Detachment Of Device Component (1104); Deflation Problem (1149)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 06/17/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during a laparoscopic sleeve gastrectomy with hysterectomy, the trocar device was used as a stapler port and while inserting the powered stapler, there was a rapid desufflation from port inside.The surgeon tried to manage and fired the stapler.They used a bladeless trocar and fired the remaining cartridges.After the sleeve gastrectomy, the surgeon proceeded for hysterectomy and unfortunately blue color round was seen in the abdominal area and it¿s the trocar sleeve.The sleeve in the trocar cannula fell into the cavity of the patient and was retrieved.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) led an evaluation of one no blade device.The visual inspection of the device noted that the circular seal was disengaged.The cannula, trocar and envelope seal were intact.The obturator was received.Pmv performed functional testing; the device passed an air leak test.The envelope seal passes however the instrument seal leaks during manual manipulation using an endo peanut.Records from each manufacturing lot are thoroughly reviewed to ensure that products are released meeting all quality release specifications at the time of manufacture.Analysis concluded there were no assembly component related condition.Replication of the disengaged circular seal may occur when mishandled during clinical application.The root cause of the observed damage was misuse of the product which would have caused or contributed to the reported incident.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VERSAONE
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer (Section G): DAVIS & GECK CARIBE LTD; zona franca de san isidro; santo domingo 0101 ; DO 0101
• Manufacturer Contact: lisa hernandez ; 60 middletown ave.; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7658130
• MDR Text Key: 113006797
• Report Number: 9612501-2018-01231
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 20884521185972
• UDI-Public: 20884521185972
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K160230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: ONB15STF
• Device Catalogue Number: ONB15STF
• Device Lot Number: J7G1145X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1