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

Catalog Number 6001-400-000

Device Problem Imprecision (1307)

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

Event Date 08/20/2015

Event Type  malfunction  

Event Description

It was reported that during a profess surgery at the healthcare facility, the navigation system was inaccurate by up to 5 cm.It was reported that the procedure was completed successfully without a clinically significant delay.No adverse consequences or medical intervention were reported.

Manufacturer Narrative

The reported event that the initial anatomical registration was off by 2 mm and that the video registration was off by 5 cm was able to be confirmed by the associate sales representative who was present during the case.The device was not returned for evaluation.

Event Description

It was reported that during a profess surgery at the healthcare facility, the navigation system was inaccurate by up to 5 cm.It was reported that the procedure was completed successfully without a clinically significant delay.No adverse consequences or medical intervention were reported.

• Brand Name: PROFESS(TM) SOFTWARE
• 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 (MDR); boetzingerstr. 41; freiburg 79111 ; GM 79111
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 5080218
• MDR Text Key: 25898717
• Report Number: 0001811755-2015-03378
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/20/2015

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: 6001-400-000
• Device Lot Number: VERSION 1.0-9
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/20/2015
• Initial Date FDA Received: 09/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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