MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER SONICISION; INSTRUMENT, ULTRASONIC SURGICAL

Model Number SCD396

Device Problem Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2019

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: one device was returned for evaluation.The returned product did not meet specification as received.Visual inspection of the disposable hand piece revealed that the waveguide had fractured and the tip had broken off.The broken piece was not returned with the device.The reported condition was confirmed.The waveguide was inspected under magnification to identify the point of initial contact that caused the fracture and eventual break.Investigation personnel concluded that the titanium waveguide was in use when it fractured.Further investigation revealed that the waveguide was excessively torqued to the side during use causing it to come in contact with the moving jaw of the device while it was being activated.This contact caused the waveguide to crack and eventually break off.The investigation identified the root cause of the reported event to be user error.The device instructions for use currently contain a warning against contact between the dissector tip and metal objects (hemostats, clips, staples, retractors, etc.) during activation.This issue is specific to ultrasonic dissectors.The instructions for use (ifu) notes that device users should visually insp ect all system components for breaks, cracks, nicks, or other damages prior to use.Ifu also states: do not use damaged components.Use of damaged components may result in injury to the patient or user.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during total laparoscopic hysterectomy, the active blade broke and fell into patients cavity but retrieved.They used another like device to complete the procedure.There was no patient injury.

• Brand Name: SONICISION
• Type of Device: INSTRUMENT, ULTRASONIC SURGICAL
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 8358485
• MDR Text Key: 136767935
• Report Number: 1717344-2019-00218
• Device Sequence Number: 1
• Product Code: LFL
• UDI-Device Identifier: 20884521052663
• UDI-Public: 20884521052663
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K101797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/21/2019

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: 09/25/2023
• Device Model Number: SCD396
• Device Catalogue Number: SCD396
• Device Lot Number: 82620220X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2019
• Initial Date FDA Received: 02/21/2019
• Date Device Manufactured: 09/26/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1