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

Model Number OMS-PDB1000

Device Problems Inflation Problem (1310); Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, prior to partial nephrectomy under scope view, the scrub nurse checked if the balloon would inflate, but found air was leaking from somewhere and the balloon did not inflate.The procedure was completed with another device.There was no patient involvement.

Manufacturer Narrative

Additional information: d10, g4, h3, h6.H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted sharp damage on the dissector balloon.It was reported that the balloon did not inflate easily and had an air leak.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: care must be exercised during insertion of the balloon as well as during the course of the procedure to avoid damaging the balloon with other instruments.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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
• MDR Report Key: 10437640
• MDR Text Key: 203876548
• Report Number: 2647580-2020-02659
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 10884521067929
• UDI-Public: 10884521067929
• Combination Product (y/n): N
• PMA/PMN Number: K935426
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 10/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Model Number: OMS-PDB1000
• Device Catalogue Number: OMS-PDB1000
• Device Lot Number: P9M1293Y
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2020
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1