MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO NEPTUNE 2 ROVER ULTRA (120V); APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED

Model Number 0702001000

Device Problem Thermal Decomposition of Device (1071)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2020

Event Type  malfunction  

Event Description

It was reported by the customer that during a procedure, the device's power cord burned.The procedure was completed without further use of the device.No significant delay, no adverse consequences and no medical intervention were reported.

• Brand Name: NEPTUNE 2 ROVER ULTRA (120V)
• Type of Device: APPARATUS, SUCTION, WARD USE, PORTABLE, AC-POWERED
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: zach baker ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 10178370
• MDR Text Key: 195895824
• Report Number: 0001811755-2020-01508
• Device Sequence Number: 1
• Product Code: JCX
• UDI-Device Identifier: 07613154522309
• UDI-Public: 07613154522309
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132671
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 0702001000
• Device Catalogue Number: 0702001000
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2011
• 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