MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SONICBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP; INSTRUMENT

Model Number SB-0535FC

Device Problems Break (1069); Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2019

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned to olympus medical systems corp.(omsc) for evaluation.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

During a total laparoscopic hysterectomy b/l pelvic lymph node dissection, one sb-0520fc and three sb-0535fcs were used.It was informed that the probe tip got broken inside the abdomen during dissection of the major pelvic vessel and auto activation of the hand piece during blunt dissection without energy with one sb-0520fc and three sb-0535fcs.The intended procedure was completed with another device.There was no patient injury reported.After this event, an olympus field service engineer found the generator was working satisfactorily, foot switch and transducer also worked satisfactorily.No further information was provided.This is the report regarding the breakage of the probe and auto activation without pressing any button with the second sb-0535fc.

Manufacturer Narrative

This is a supplemental report to provide additional information.A part of the subject device was returned to olympus medical systems corp.(omsc) for evaluation.The probe was broken off at 16 mm from the distal end.The probe had a mark contacted with the grasping section.The fracture surface of the probe showed that crack developed from the mark.The proximal side of the tissue pad was worn.The grasping section had a contact mark.There was foreign material on the substrate inside the handle.After the foreign material was removed, the electrodes were not conducted automatically.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, it was known that the tissue pad at the proximal side was damaged since the user activated output while the subject device was grasping a thick and hard tissue.It was also known that the proximal side of the grasping section and the probe came into contact since the tissue pad at the proximal side was damaged, consequently the probe cracked, and besides the probe was broken off when the probe was subjected to a load.In addition, omsc assumes that the auto activation occurred since the liquid invaded into the circuit board, and then the subject device became conductive.The above device handling has warned in the instruction manual as follows.During the treatment, do not activate output while applying the probe tip to the tissue with a strong force, grasping thick tissue or twisting the handle.Also, do not activate the output, while torque is applied to tissue over the handle, in this instance release the torque, re-grasp the tissue and re-activate output.Otherwise, the probe tip and/or grasping section may be damaged, which may result in falling of the probe tip and/or tissue pad.Do not submerge the handle in any liquid.

• Brand Name: SONICBEAT 5 MM, 35 CM, FRONT-ACTUATED GRIP
• Type of Device: INSTRUMENT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 9517304
• MDR Text Key: 205156881
• Report Number: 8010047-2019-04597
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• PMA/PMN Number: K111202
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 04/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SB-0535FC
• Device Lot Number: 8ZK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1