MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S; ULTRASONIC SURGICAL DEVICE

Model Number TB-0535FCS

Device Problem Use of Device Problem (1670)

Patient Problem Injury (2348)

Event Date 10/27/2020

Event Type  Injury  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation, because the subject device was discarded by the user.Therefore, the exact cause of the reported event could not be conclusively determined.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

We received the following report.*during a total laparoscopic hysterectomy and bilateral salpingo-oophorectomy, the subject device was used.Probe damage error occurred.The intended procedure was completed with another device.After the procedure, a cystoscopy was performed.During this procedure it was found that the right ureter was cut by mistake and would need repair with laparotomy.It was also provided the following information later; on the next day of the procedure, the patient is in good health.The surgeon found that the ureter had a small cut and was not fully transected.The repair was a small stitch of the ureter.The surgeon said that he did not dissect far enough down the ureter and therefore hit the ureter where it was not exposed.Where the ureter was not exposed, its path took a small kink and was not where the surgeon expected it to lie deep in the pelvis, hence he contacted the ureter with the device unintentionally.The surgeon said that the device functioned as expected.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for evaluation, because the subject device was discarded by the user.We could not confirm the phenomenon was pointed out because it was not returned to us.Although the lot number is unknown, all devices are inspected at the manufacturing site, and only those that pass the inspection are shipped.We could not specify the cause because we could not confirm the device.From the reported event, damaged the ureters was likely occurred due to unintentional contact with a heated probe.The above device handling has warned in the instruction manual as follows.*the grasping section and probe tip become hot due to extended ultrasonic output.Do not let it come in contact with tissues other than the target tissue.

• Brand Name: THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP TYPE S
• Type of Device: ULTRASONIC SURGICAL DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 10849847
• MDR Text Key: 216650073
• Report Number: 8010047-2020-09002
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04953170409677
• UDI-Public: 04953170409677
• Combination Product (y/n): N
• PMA/PMN Number: K172610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TB-0535FCS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention