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 Increase in Suction (1604)

Patient Problem Laceration(s) (1946)

Event Date 11/15/2022

Event Type  Injury  

Manufacturer Narrative

Device not returned.

Event Description

Per the customer, it was reported that a patient's bladder was "nicked" during a surgery.Per the customer during the procedure "there was perhaps to much suction," from the neptune.Additional information has been requested from the user facility.

Event Description

Per the customer, it was reported that a patient's bladder was "nicked" during a surgery.Per the customer during the procedure "there was perhaps to much suction," from the neptune.After multiple follow up attempts, no additional information is available from the user facility.

Manufacturer Narrative

Update: b1, d9, h3, h6.Correction: follow-up report submitted to document the device was not available for evaluation.Update to document the event was a serious injury with no known device malfunction.H3 other text : device not returned.

• 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: 16003728
• MDR Text Key: 305689814
• Report Number: 3015967359-2022-02461
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 0703001000
• Device Catalogue Number: 0703001000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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