Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE HANDPIECE WITH HIGH FLOW TIP; LAVAGE, JET
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE HANDPIECE WITH HIGH FLOW TIP; LAVAGE, JET Back to Search Results
Catalog Number 0210114000
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/01/2019
Event Type  malfunction  
Event Description
The user facility reported that the device started to leak around the battery box when hooked up to irrigation during a procedure.There was no delay, no medical intervention, and no adverse consequences.
 
Manufacturer Narrative
Additional information:.
 
Event Description
The user facility reported that the device started to leak around the battery box when hooked up to irrigation during a procedure.There was no delay, no medical intervention, and no adverse consequences.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
INTERPULSE HANDPIECE WITH HIGH FLOW TIP
Type of Device
LAVAGE, JET
Manufacturer (Section D)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 00615
MDR Report Key8627803
MDR Text Key145639540
Report Number0001811755-2019-01765
Device Sequence Number1
Product Code FQH
UDI-Device Identifier34546540673566
UDI-Public34546540673566
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 05/30/2019
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
Device Operator Health Professional
Device Catalogue Number0210114000
Device Lot Number18191032
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/16/2019
Initial Date Manufacturer Received 05/01/2019
Initial Date FDA Received05/21/2019
Supplement Dates Manufacturer Received05/24/2019
Supplement Dates FDA Received05/30/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-