MAUDE Adverse Event Report: STRYKER INSTRUMENTS-INAGI SONOPET FOOT PEDAL; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number 5450850007

Device Problem Failure to Shut Off (2939)

Patient Problem No Patient Involvement (2645)

Event Date 07/13/2016

Event Type  malfunction  

Event Description

It was reported by the manufacturer sales representative that the foot pedal made the handpiece continuously run.No patient involvement, no delay, no medical intervention, and no adverse consequences were reported.

• Brand Name: SONOPET FOOT PEDAL
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-INAGI; 1131-1 higashi naganuma; inagi 206-0 802
• Manufacturer (Section G): STRYKER INSTRUMENTS-INAGI; 1131-1 higashi naganuma; inagi 206-0 802
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 6913275
• MDR Text Key: 88130346
• Report Number: 0008043928-2017-00073
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010309
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5450850007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2016
• Date Manufacturer Received: 07/13/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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