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
Medical Device Problem Code	Increase in Suction (1604)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	11/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not returned.
Event or Problem 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 or Problem 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.
Additional 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)
• Common Device Name: 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
• Report Number: 3015967359-2022-02461
• Device Sequence Number: 6738171
• Product Code: JCX
• UDI-Device Identifier: 07613327116656
• UDI-Public: 07613327116656
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K153407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2022
• Supplement Date Received by Manufacturer: 12/18/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 12/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown