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

Model Number COVSCD396

Device Problems Difficult to Open or Close (2921); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/22/2019

Event Type  malfunction  

Event Description

Upon placing battery there was a delay with the green indicator light.Doctor complained of the jaws sticking and not opening.New battery was tried first then another device was opened and worked fine.Manufacturer response for sonicision, sonicision (per site reporter).There has not been a response.

• Brand Name: SONICISION
• Type of Device: SCALPEL, ULTRASONIC, REPROCESSED
• Manufacturer (Section D): STERILMED, INC.; 5010 cheshire parkway n; suite 2; plymouth MN 55446
• MDR Report Key: 9876904
• MDR Text Key: 184889045
• Report Number: 9876904
• Device Sequence Number: 1
• Product Code: NLQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/24/2020

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
• Device Operator: Health Professional
• Device Model Number: COVSCD396
• Device Catalogue Number: COVSCD396
• Device Lot Number: 92310263X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/25/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15695 DA