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

Model Number VERSION 1.0-12

Device Problem Imprecision (1307)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 09/22/2016

Event Type  Injury  

Event Description

It was reported that approximately 30 minutes into an ent procedure of the ethmoid and frontal sinus area, the surgeon complained that a system inaccuracy occurred.It was further reported that the surgeon chose to continue with the surgery and did not re-register his tools.It was further reported that approximately 20 minutes later, the surgeon did re-register the tools anatomically and determined that the system was inaccurate in the ethmoid and frontal sinuses by approximately 1cm, inferiorly.It was further reported that the surgeon proceeded with the procedure and inadvertently reduced dura mater, thinking it was bone, resulting in a cerebral spinal fluid leak.It was further reported that the leak was repaired with duramatrix during the procedure.No clinically significant delays or adverse consequences to the patient were reported post-op.

Event Description

It was reported that approximately 30 minutes into an ent procedure of the ethmoid and frontal sinus area, the surgeon complained that a system inaccuracy occurred.It was further reported that the surgeon chose to continue with the surgery and did not re-register his tools.It was further reported that approximately 20 minutes later, the surgeon did re-register the tools anatomically and determined that the system was inaccurate in the ethmoid and frontal sinuses by approximately 1cm, inferiorly.It was further reported that the surgeon proceeded with the procedure and inadvertently reduced dura mater, thinking it was bone, resulting in a cerebral spinal fluid leak.It was further reported that the leak was repaired with duramatrix during the procedure.No clinically significant delays or adverse consequences to the patient were reported post-op.

Event Description

It was reported that approximately 30 minutes into an ent procedure of the ethmoid and frontal sinus area, the surgeon complained that a system inaccuracy occurred.It was further reported that the surgeon chose to continue with the surgery and did not re-register his tools.It was further reported that approximately 20 minutes later, the surgeon did re-register the tools anatomically and determined that the system was inaccurate in the ethmoid and frontal sinuses by approximately 1cm, inferiorly.It was further reported that the surgeon proceeded with the procedure and inadvertently reduced dura mater, thinking it was bone, resulting in a cerebral spinal fluid leak.It was further reported that the leak was repaired with duramatrix during the procedure.No clinically significant delays or adverse consequences to the patient were reported post-op.

• 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; boetzingerstr. 41; freiburg D-791 11
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6043170
• MDR Text Key: 57924445
• Report Number: 0001811755-2016-02599
• 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,Followup,Followup
• Report Date: 09/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VERSION 1.0-12
• Device Catalogue Number: 6001-400-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/22/2016
• Initial Date FDA Received: 10/20/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/26/2016; 11/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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
• Patient Outcome(s): Required Intervention