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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE IRRIGATION ONLY HANDPIECE; LAVAGE, JET
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STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE IRRIGATION ONLY HANDPIECE; LAVAGE, JET Back to Search Results
Catalog Number 0210200000
Medical Device Problem Code Leak/Splash (1354)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/25/2018
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that the device had water leaking from the battery box during a procedure.There was no delay, no medical intervention, and no adverse consequences.
 
Event or Problem Description
The user facility reported that the device had water leaking from the battery box during a procedure.There was no delay, no medical intervention, and no adverse consequences.
 
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Brand Name
INTERPULSE IRRIGATION ONLY HANDPIECE
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 Key8051058
Report Number0001811755-2018-02422
Device Sequence Number16596063
Product Code FQH
UDI-Device Identifier34546540144264
UDI-Public34546540144264
Combination Product (Y/N)N
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial,Followup
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 Number0210200000
Device Lot Number18085022
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/07/2018
Initial Date Received by Manufacturer 10/25/2018
Supplement Date Received by Manufacturer12/04/2018
Initial Report FDA Received Date11/08/2018
Supplement Report FDA Received Date12/05/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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