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 07/27/2015

Event Type  malfunction  

Manufacturer Narrative

The device is not available for evaluation at this time.

Event Description

It was reported that during a profess navigation endoscopic sinus surgery at the healthcare facility, the system displayed an inaccuracy of at least 3mm during registration of the patient.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.

Manufacturer Narrative

The reported event was confirmed by the assistant sales representative present.After review of computer tomography images from the procedure associated with the event, no device failures were identified and there were no indications that the system did not function as expected.The device was not returned for evaluation.

Event Description

It was reported that during a profess navigation endoscopic sinus surgery at the healthcare facility, the system displayed an inaccuracy of at least 3mm during registration of the patient.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: 5013064
• MDR Text Key: 23392520
• Report Number: 0001811755-2015-02999
• 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
• Report Date: 07/27/2015

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: Not provided
• Initial Date FDA Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: No
• 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