MAUDE Adverse Event Report: STERILMED, INC. SONICISION CORDLESS ULTRASONIC DISSECTOR; SCALPEL, ULTRASONIC, REPROCESSED

Catalog Number	COVSCD396
Medical Device Problem Codes	Smoking (1585); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been returned for analysis.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent an unknown procedure with a sonicision cordless ultrasonic dissector and the tip of device began smoking and a piece of the tip detached during procedure.The white coating on the tip of the device started to come apart during use and possibly melted off.Tiny fragment of white plastic coating completely detached inside of the patient.Tip of instrument looked charred.All visible material was retrieved successfully.There was no patient consequence.This event has been assessed as reportable.
Additional Manufacturer Narrative
Additional information was received via medsun/user facility report (b)(4) on (b)(6) 2019.It was noted that a laparoscopic surgery was performed on a (b)(6)-year-old female patient, weighing (b)(6) kgs, not hispanic/latino and race of white.Updated sections: patient identifier, sex, weight, ethnicity, describe event or problem., initial reporter also sent report to fda, report source, date received by manufacturer.Manufacturer's ref.No: (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent an unknown procedure with a sonicision cordless ultrasonic dissector and the tip of device began smoking and a piece of the tip detached during procedure.The reported issue could not be confirmed because the product said to be involved was not received for evaluation.As the device was not returned for evaluation the visual and functional inspections could not be performed.Per the failure modes and effects analysis (fmea) for this device, possible cause for this hazard is operator error - activation of the device without tissue between the blade and the pad.A manufacturing record evaluation was performed for the finished device lot# 2081413, and no non-conformances were identified.Manufacturer's ref.No: (b)(4).

• Brand Name: SONICISION CORDLESS ULTRASONIC DISSECTOR
• Common Device Name: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• MDR Report Key: 8672133
• Report Number: 2134070-2019-00136
• Device Sequence Number: 1941877
• Product Code: NLQ
• UDI-Device Identifier: 10888551008020
• UDI-Public: 10888551008020
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K143562
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/13/2019

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 Expiration Date: 03/29/2020
• Device Catalogue Number: COVSCD396
• Device Lot Number: 2081413
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 06/10/2019; 07/08/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 07/01/2019; 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 115