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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)

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OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP UNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES) Back to Search Results
Model Number TB-0535FC
Device Problem Device Displays Incorrect Message (2591)
Patient Problem Blood Loss (2597)
Event Date 05/02/2019
Event Type  malfunction  
Event Description
During case, the thunderbeat unit reported a "cut & seal error". No harm to patient. Another thunderbeat opened. Estimated blood loss: less than 5 ml. The stomach was identified. Approximately 1/4 of the stomach was in the mediastinum. We grasped the stomach and we were able to partially reduce it. I then opened the pars flaccida portion of the gastrohepatic ligament, carried this up to the right crus. I then opened up the hernia sac right at the edge of the right crus. I carried this up to the phrenoesophageal ligament and then down the left crus, continually reducing and effacing the hernia sac. We then grasped the fundus which was now able to be reduced and took down some short gastric's taking this up to the base of the left crus. There was a more posterior row of short gastric that we took down as well with the thunderbeat. We were able to fairly easily reduce the stomach and the hernia sac. I then resected the hernia sac using the thunderbeat. We were then able to get around retroesophageally as well. There was a posterior hernia sac here that was also resected. We then placed a penrose drain around the ge junction and dissected up in the mediastinum mobilizing the esophagus. Once we had obtained good intra-abdominal length of esophagus, we then closed the diaphragmatic defect primarily using a 2-0 xxxxxx suture. The diaphragm came together easily.
 
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Brand NameTHUNDERBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP
Type of DeviceUNIT, ELECTROSURGICAL, ENDOSCOPIC (WITH OR WITHOUT ACCESSORIES)
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2400 ringwood ave.
san jose CA 95131
MDR Report Key8657984
MDR Text Key146641443
Report Number8657984
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/03/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/31/2019
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberTB-0535FC
Device Lot NumberKR824648
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA05/03/2019
Event Location Hospital
Date Report to Manufacturer05/31/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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