MAUDE Adverse Event Report: US SURGICAL PUERTO RICO PDB; LASER INSTRUMENT, SURGICAL, POWERED

Model Number OMS-PDBS2

Device Problems Difficult to Remove (1528); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2020

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 laparoscopic nephrectomy, the balloon was inserted under the retroperitoneum.After a laparoscope was inserted and air was injected, when attempted to remove the laparoscope, the cannula was found to be bent, so removal was difficult.Another scope was used to complete the case.There was no patient injury.

• Brand Name: PDB
• Type of Device: LASER INSTRUMENT, SURGICAL, POWERED
• 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: 10138675
• MDR Text Key: 194652627
• Report Number: 2647580-2020-01799
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 10884521067943
• UDI-Public: 10884521067943
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K946002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: OMS-PDBS2
• Device Catalogue Number: OMS-PDBS2
• Device Lot Number: P9K1397Y
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/26/2020
• Date Device Manufactured: 10/21/2019
• 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