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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SUCTION TUBE, 2.7MM RIGHT POSTERIOR FOSSA NEUROLOGICAL STEREOTAXIC INSTRUMENT

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STRYKER INSTRUMENTS-KALAMAZOO SUCTION TUBE, 2.7MM RIGHT POSTERIOR FOSSA NEUROLOGICAL STEREOTAXIC INSTRUMENT Back to Search Results
Catalog Number 6001-088-227
Device Problem Disassembly (1168)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/28/2017
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: follow-up report submitted to document device evaluation results.
 
Event Description
It was reported that during a navigation procedure the angled suction tip was bent during the case. The device's tip being bent can lead to permanent impairment of body function or permanent damage to a body structure there was no impact to the patient and no significant procedural delays. The procedure was completed successfully.
 
Event Description
It was reported that during a navigation procedure the angled suction tip was bent during the case. The device's tip being bent can lead to permanent impairment of body function or permanent damage to a body structure there was no impact to the patient and no significant procedural delays. The procedure was completed successfully.
 
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Brand NameSUCTION TUBE, 2.7MM RIGHT POSTERIOR FOSSA
Type of DeviceNEUROLOGICAL STEREOTAXIC INSTRUMENT
Manufacturer (Section D)
STRYKER INSTRUMENTS-KALAMAZOO
4100 east milham avenue
kalamazoo MI 49001
Manufacturer (Section G)
STRYKER INSTRUMENTS-FREIBURG
boetzingerstr. 41
freiburg D-791 11
Manufacturer Contact
zachary baker
4100 east milham avenue
kalamazoo, MI 49001
2693237700
MDR Report Key7145489
MDR Text Key192077815
Report Number0001811755-2017-02488
Device Sequence Number1
Product Code HAW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K993239
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/26/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number6001-088-227
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/29/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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