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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 0210212000
Device Problem Disassembly (1168)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/06/2014
Event Type  malfunction  
Event Description
It was reported that it was discovered the o-ring of the interpulse handpiece with soft tissue tip during a procedure.A back up device was used to complete the procedure successfully, with no patient or user injuries and no adverse consequences.
 
Manufacturer Narrative
The unit was received in the original packaging.Upon visual inspection, the black o-ring on the tip was observed to be broken, thus confirming the reported condition.The unit was not used.No further assembly issues were observed.A definite root cause could not be determined.The device was scrapped at the manufacturer.
 
Event Description
It was reported that it was discovered the o-ring of the interpulse handpiece with soft tissue tip during a procedure.A back up device was used to complete the procedure successfully, with no patient or user injuries and no adverse consequences.
 
Manufacturer Narrative
A follow up report will be filed after the device is received and the quality investigation has been completed.Not received.
 
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Brand Name
INTERPULSE HANDPIECE WITH SOFT TISSUE TIP
Type of Device
LAVAGE, JET
Manufacturer (Section D)
STRYKER INSTRUMENTS-PUERTO RICO
las palmas industrial park
highway #3, km 130.2
arroyo MI 49001 006
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 Key4220604
MDR Text Key5058585
Report Number0001811755-2014-03910
Device Sequence Number1
Product Code FQH
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 10/06/2014
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 Number0210212000
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/19/2014
Initial Date FDA Received11/03/2014
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received12/04/2014
Was Device Evaluated by Manufacturer? Yes
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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