MAUDE Adverse Event Report: STRYKER INSTRUMENTS-INAGI SONOPET STRAIGHT HANDPIECE, UNIVERSAL; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	5450840000
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/27/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during testing conducted by a manufacturer sales representative at the user facility, there was no irrigation.A lack of irrigation in the device is known to cause overheating.The user facility reported that there was no patient involvement, no delay, no medical intervention, and no adverse consequences.
Additional Manufacturer Narrative
Follow up being submitted for investigation results.
Event or Problem Description
It was reported that during testing conducted by a manufacturer sales representative at the user facility, there was no irrigation.A lack of irrigation in the device is known to cause overheating.The user facility reported that there was no patient involvement, no delay, no medical intervention, and no adverse consequences.

• Brand Name: SONOPET STRAIGHT HANDPIECE, UNIVERSAL
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-INAGI; 1131-1 higashi naganuma; inagi 206-0 802
• MDR Report Key: 7800862
• Report Number: 0008043928-2018-00087
• Device Sequence Number: 16609872
• Product Code: LFL
• UDI-Device Identifier: 07613327291933
• UDI-Public: 07613327291933
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K010309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2018

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
• Operator of Device: Other
• Device Catalogue Number: 5450840000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 11/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1