MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO INRPLS HP W/COAX MULTI-ORIFICE; LAVAGE, JET

Catalog Number	0210158000
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Customer discarded.
Event or Problem Description
The user facility reported, the device was leaking fluid from the battery pack during a procedure.No medical intervention, no delay and no adverse consequences.

• Brand Name: INRPLS HP W/COAX MULTI-ORIFICE
• Common Device Name: LAVAGE, JET
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 00615
• MDR Report Key: 8134702
• Report Number: 0001811755-2018-02674
• Device Sequence Number: 1233967
• Product Code: FQH
• UDI-Device Identifier: 37613327351003
• UDI-Public: 37613327351003
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0210158000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 12/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1