MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP NEPTUNE 3 ROVER (120V); APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Model Number 0703001000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pneumothorax (2012)

Event Date 07/29/2022

Event Type  Injury  

Event Description

It was reported that during an upper lobectomy procedure the patient developed an air leak that needed to be sealed.The reported event did not indicate the device malfunctioned.The procedure was completed successfully.

Manufacturer Narrative

H6 device evaluation: follow-up report submitted to document the device was not available for evaluation.H3 other text : there was no request for service from the customer.

Event Description

It was reported that during an upper lobectomy procedure the patient developed an air leak that needed to be sealed.The reported event did not indicate the device malfunctioned.The procedure was completed successfully.

• Brand Name: NEPTUNE 3 ROVER (120V)
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: colette chung ; 1941 stryker way; portage, MI 49002 ; 2693237700
• MDR Report Key: 15585882
• MDR Text Key: 301552991
• Report Number: 3015967359-2022-01898
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 07613327116656
• UDI-Public: 07613327116656
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 0703001000
• Device Catalogue Number: 0703001000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other