MAUDE Adverse Event Report: STRYKER INSTRUMENTS-INAGI SONOPET 110V CONSOLE WITH FOOT PEDAL AND POLE; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number 5450850000

Device Problem Inability to Irrigate (1337)

Patient Problem No Patient Involvement (2645)

Event Date 09/09/2016

Event Type  malfunction  

Event Description

It was reported that during testing conducted at the user facility the irrigation priming function did not work.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

This follow-up report is being submitted due to the investigation being completed.

Event Description

It was reported that during testing conducted by the sales representative at the user facility the irrigation priming function did not work.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

• Brand Name: SONOPET 110V CONSOLE WITH FOOT PEDAL AND POLE
• 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: 6010461
• MDR Text Key: 57341616
• Report Number: 0008043928-2016-00038
• Device Sequence Number: 1
• Product Code: ILJ
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 5450850000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2004
• 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