MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PROFESS(TM) CURVED 70° SUCTION; EAR, NOSE, AND THROAT STEREOTAXIC INSTRUMENT

Catalog Number 6001-410-070

Device Problem Imprecision (1307)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2016

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure conducted at the user facility the device was inaccurate.No adverse consequences or procedural delays were reported with this event.

Event Description

It was reported that during a surgical procedure conducted at the user facility the device was inaccurate.No adverse consequences or procedural delays were reported with this event.

• Brand Name: PROFESS(TM) CURVED 70° SUCTION
• Type of Device: EAR, NOSE, AND THROAT 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: 6200747
• MDR Text Key: 63200804
• Report Number: 0001811755-2016-02913
• Device Sequence Number: 1
• Product Code: PGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141551
• 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: 05/19/2017

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 Number: 6001-410-070
• Device Lot Number: 246181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 12/22/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/19/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/02/2016
• 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