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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE HANDPIECE WITH SOFT TISSUE TIP; LAVAGE, JET
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STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE HANDPIECE WITH SOFT TISSUE TIP; LAVAGE, JET Back to Search Results
Catalog Number 0210112000
Medical Device Problem Code Accessory Incompatible (1004)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 05/17/2019
Type of Reportable Event Malfunction
Event or Problem Description
The user facility reported that the tip could not be connected to the handpiece prior to a procedure.There was no patient impact, no delay, no medical intervention, and no adverse consequences.
 
Event or Problem Description
The user facility reported that the tip could not be connected to the handpiece prior to a procedure.There was no patient impact, no delay, no medical intervention, and no adverse consequences.
 
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Brand Name
INTERPULSE HANDPIECE WITH SOFT TISSUE TIP
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 Key8688337
Report Number0001811755-2019-01995
Device Sequence Number2359383
Product Code FQH
UDI-Device Identifier34546540144233
UDI-Public34546540144233
Combination Product (Y/N)N
PMA/510(K) Number
EXEMPT
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 07/01/2019
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 Number0210112000
Device Lot Number18187012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/11/2019
Initial Date Received by Manufacturer 06/04/2019
Supplement Date Received by Manufacturer06/27/2019
Initial Report FDA Received Date06/11/2019
Supplement Report FDA Received Date07/01/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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