MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO SONIC CONTROL KNIFE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number 5450815100

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Laceration(s) (1946)

Event Date 07/23/2015

Event Type  Injury  

Manufacturer Narrative

Not available for evaluation.

Event Description

It was reported that the sonic control knife was being used in a cervical laminectomy procedure when the dura was torn.The procedure was completed without a clinically significant delay.There were no permanent injuries or harm as a result of this event for the patient.

• Brand Name: SONIC CONTROL KNIFE
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 5013934
• MDR Text Key: 23427911
• Report Number: 0001811755-2015-03008
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K020220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Report Date: 07/23/2015

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 5450815100
• Device Lot Number: 0237950
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: STRAIGHT HANDPIECE 5450840000 SERIAL:UNKNOWN
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR