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 05/04/2015

Event Type  malfunction  

Event Description

It was reported that during a balloon sinuplasty with profess, inaccuracies of 5-8 mm were seen with the video registration.The procedure was completed successfully without a delay and with navigation; no adverse consequences or medical intervention were reported.

Manufacturer Narrative

The lot version number of the software was added.

Event Description

It was reported that during a balloon sinuplasty with profess, inaccuracies of 5-8 mm were seen with the video registration.The procedure was completed successfully without a delay and with navigation; no adverse consequences or medical intervention were reported.

Manufacturer Narrative

During the evaluation, the quality of the ct images was identified as a potential cause of the reported information.

Event Description

It was reported that during a balloon sinuplasty with profess, inaccuracies of 5-8 mm were seen with the video registration.The procedure was completed successfully without a delay and with navigation; 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: 4771813
• MDR Text Key: 5949831
• Report Number: 0001811755-2015-01756
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2015

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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/14/2015
• Initial Date FDA Received: 05/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/18/2015
• 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