MAUDE Adverse Event Report: OLYMPUS CORPORATION OF THE AMERICAS THUNDERBEAT; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number 5MM

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 04/28/2016

Event Type  malfunction  

Event Description

When using device, the device defaulted and while troubleshooting, it was noticed white was dislodged from jaws.Chart reviewed.No mention of event in surgeon's procedural notes.Procedural notes state: "the utero-ovarian ligaments and round ligaments were bilaterally sealed and transected with the 5mm thunderbeat.The anterior leaf of the broad ligament was then carefully dissected anteriorly, creating the bladder flap.The bladder was carefully dissected off the cervix.The uterine vessels were bilaterally skeletonized.The vessels were bilaterally doubly sealed with the device prior to sealing and transecting with the device.Hemostasis was excellent.The uterus was amputated from the vagina with monopolar cautery using the device.Again, hemostasis was noted to be excellent.".

• Brand Name: THUNDERBEAT
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): OLYMPUS CORPORATION OF THE AMERICAS; 3500 corporate parkway; central valley PA 18034
• MDR Report Key: 5655562
• MDR Text Key: 45209997
• Report Number: 5655562
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/09/2016,05/12/2016

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: Physician
• Device Expiration Date: 02/16/2019
• Device Model Number: 5MM
• Device Catalogue Number: TB0535FC
• Device Lot Number: MK987660
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/09/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/09/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 89