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

Catalog Number COVSCD396

Device Problems Smoking (1585); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not yet been returned for analysis.Manufacturer's ref.No: (b)(4).

Event 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.

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).

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
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer (Section G): STERILMED, INC.; 5010 cheshire parkway; ste 2; plymouth MN 55446
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 8672133
• MDR Text Key: 147300039
• Report Number: 2134070-2019-00136
• Device Sequence Number: 1
• Product Code: NLQ
• UDI-Device Identifier: 10888551008020
• UDI-Public: 10888551008020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2020
• Device Catalogue Number: COVSCD396
• Device Lot Number: 2081413
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2019
• Initial Date FDA Received: 06/05/2019
• Supplement Dates Manufacturer Received: 06/10/2019; 07/08/2019
• Supplement Dates FDA Received: 07/01/2019; 07/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 115