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

Catalog Number 6001-088-227

Device Problem Bent (1059)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/21/2016

Event Type  malfunction  

Event Description

It was reported that the tip of the device was identified to be bent at the user facility.Although requested, the user facility was unable to provide any additional information regarding the event.

Manufacturer Narrative

The reported event that the unit was bent during an unknown time was confirmed through the device inspection.During functional inspection it was observed that the tip of the suction tube was deformed.The tube of the device is delicate and are susceptible to bending due to the small diameter of the tube and should be handled with special care.Any impact will cause product damage or operational failure due to battery movement.

Event Description

It was reported that the tip of the device was identified to be bent at the user facility.Although requested, the user facility was unable to provide any additional information regarding the event.

• Brand Name: SUCTION TUBE, 2.7MM RIGHT POSTERIOR FOSSA
• Type of Device: NEUROLOGICAL 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: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6184848
• MDR Text Key: 62678852
• Report Number: 0001811755-2016-02860
• Device Sequence Number: 1
• Product Code: HAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6001-088-227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1