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 first 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 14 mm from the distal end.There was scratch on the probe.The fracture surface of the probe showed that crack developed from the scratch.There were 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 probe was cracked when the user activated output contacting with metal or something hard object such as metal clips, stapler, or other instruments, 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.Do not grasp or let the probe tip contact hard objects such as metal clips, stapler, or other instruments (e.G., uterine manipulator).Also, be careful to avoid contacting the probe tip with those accidentally.Particularly during activation, a scratch on the probe tip could occur due to ultrasonic vibration, which leads the probe tip to break and fall off into the body cavity.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: 9517300
• MDR Text Key: 219763200
• Report Number: 8010047-2019-04596
• 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: 86K
• 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