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

Model Number SCD396

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2021

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the waveguide was found to be broken.It was reported that the device had a loose component and the dissector prongs on the device were bent.The reported issues were confirmed.The product analysis noted evidence that the device was not used as intended.The evaluation detected an unreported condition: battery contact pin 7 bent.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: contact between the active blade and other metal objects (hemostats, clips, staples, retractors, etc.) may result in unintended damage to tissue and/or device failure.Do not use damaged components, as this may result in injury to the patient or user.It also provides specific instructions for attaching and removing the battery pack to the dissector to avoid damaging the contact pins.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during gastroplasty, the dissector had a loose pin and bent prongs.At the beginning of the surgery, when activating the device to perform sealing, it was noticed that the pin was loosened, not functioning and the replacement was required.The dissector did not come into contact into any metal instruments.There was no patient injury.Medtronic's initial evaluation of the incident device found that the tip of the waveguide had fractured and disengaged and the broken piece was returned.

• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 12882424
• MDR Text Key: 281325535
• Report Number: 1717344-2021-01584
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K101797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SCD396
• Device Catalogue Number: SCD396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2021
• Date Manufacturer Received: 11/05/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Sex: Male