MAUDE Adverse Event Report: US SURGICAL PUERTO RICO PDB; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number OMS-PDB1000

Device Problems Hole In Material (1293); Inflation Problem (1310)

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

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, the balloon was applied into the incision between the peritoneum and fascia layer on a laparoscopic inguinal hernia repair.The balloon had a hole in it and would not inflate.They opened another balloon to complete the case.There was no patient injury.

Manufacturer Narrative

Evaluation summary: post market vigilance (pmv) received one device.The visual inspection noted that the balloon was cut.The obturator was not received.The valve seal and doors appeared intact.The insufflation bulb was received.The condition of the device precludes functional testing.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 failures.Replication of the cut in the balloon 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: PDB
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer (Section G): US SURGICAL PUERTO RICO; 201 sabanetas industrial park; ponce PR 00716 4401
• Manufacturer Contact: lisa hernandez ; 60 middletown ave; north haven, CT 06473 ; 2034925563
• MDR Report Key: 7654570
• MDR Text Key: 112861573
• Report Number: 2647580-2018-03260
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521067929
• UDI-Public: 10884521067929
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K935426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: OMS-PDB1000
• Device Catalogue Number: OMS-PDB1000
• Device Lot Number: P8C1046X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2018
• 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