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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE HANDPIECE WITH COAXIAL HIGH FLOW TIP; LAVAGE, JET
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STRYKER INSTRUMENTS-PUERTO RICO INTERPULSE HANDPIECE WITH COAXIAL HIGH FLOW TIP; LAVAGE, JET Back to Search Results
Catalog Number 0210114100
Device Problem Disassembly (1168)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/14/2014
Event Type  malfunction  
Event Description
It was reported that the interpulse handpiece with coaxial high flow tip was being tested prior to a case when the tip fell off.The procedure was completed by the surgeon holding onto the tip to prevent it falling off.There were no patient or user injuries, and no adverse consequences.
 
Event Description
It was reported that the interpulse handpiece with coaxial high flow tip was being tested prior to a case when the tip fell off.The procedure was completed by the surgeon holding onto the tip to prevent it falling off.There were no patient or user injuries, and no adverse consequences.
 
Manufacturer Narrative
A follow up report will be filed after the quality investigation has been completed.
 
Manufacturer Narrative
Upon evaluation at the manufacturer, the reported event was confirmed.One (1) tip was returned at the manufacturer for evaluation.Unit label was included and lot / part number was confirmed.The suction tube was found detached from tip insert / base.Glue residues were observed in the suction tube and the tip insert, but not evenly or uniformly distributed through the bonding areas.A definite root cause could not be determined.The device was scrapped at the manufacturer.
 
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Brand Name
INTERPULSE HANDPIECE WITH COAXIAL 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 0061 5
Manufacturer (Section G)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo 0061 5
Manufacturer Contact
casey metzger
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key3738639
MDR Text Key4275657
Report Number0001811755-2014-01272
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 03/14/2014
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 Number0210114100
Device Lot Number14036012
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/07/2014
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/24/2014
Initial Date FDA Received04/10/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received07/07/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/05/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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