MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO STRAIGHT SUPERLONG; INSTRUMENT, ULTRASONIC SURGICAL

Catalog Number	5450800301
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that the sleeve melted.No further information was provided.
Event or Problem Description
It was reported that the sleeve melted.No further information was provided.
Additional Manufacturer Narrative
H6; the reported issue for a melted sleeve was confirmed on receipt of the product for evaluation.A device history record (dhr) review was not possible in this event as the lot number was reported as unknown the product was evaluated by product engineering who concluded that based on the tests completed, there is no evidence that either the tip or sleeve were defective which caused the sleeve to melt.The most likely cause was insufficient irrigation associated with the tubing setup or priming of the irrigation before use.All sonopet 1.0 tips generate heat during normal operation.To that end, adequate irrigation must be used with part numbers to prevent unintended thermal damage to the patient and the device.The associated instructions for use(ifu) for sonopet universal handpieces contains the following warning; "applied part may generate heat.Use care to avoid tissue damage due to unintended contact.Always provide adequate irrigation to the tip.".

• Brand Name: STRAIGHT SUPERLONG
• Common Device Name: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9676532
• Report Number: 0001811755-2020-00412
• Device Sequence Number: 379308
• Product Code: LFL
• UDI-Device Identifier: 37613252026618
• UDI-Public: 37613252026618
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K020220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2020

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: Health Professional
• Device Catalogue Number: 5450800301
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 02/06/2020
• Supplement Report FDA Received Date: 02/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1