MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. THUNDERBEAT OPEN EXTENDED JAW; ULTRASONIC SURGICAL DEVICE

Model Number	TB-0920OE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus medical systems corp.(omsc) for evaluation.The coating for electric insulation of the grasping section was partially missing.The manufacturing record was reviewed and found no irregularities.Based on the past similar cases, it was known that the coating for electric insulation of the grasping section was damaged when the user scraped tissue or coagulum on the grasping section with a sharp instrument.The above device handling has been warned in the instruction manual as follows; when tissue or coagulum build-up, on the grasping section or the probe tip, use a piece of moistened, soft gauze to clean the grasping section or probe tip.Do not attempt to scrape it with a sharp object such as a scalpel and tweezer.Otherwise, the grasping section, ptfe pad or probe tip may be scratched, which leads the probe tip to break and fall off into the body cavity during treatment.
Event or Problem Description
During a hemicolectomy, the subject device was used.When the subject device was connected with the generator, probe damage error occurred.The user continuously disconnected and connected the subject device but the generator alerted to replace the device.The intended procedure was completed with another device.There was no patient injury reported.On (b)(6) 2019, olympus medical systems corp.(omsc) found that the coating for electric insulation of the grasping section was partially missing.This is the report regarding the missing of the grasping section coating.

• Brand Name: THUNDERBEAT OPEN EXTENDED JAW
• Common Device Name: 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: 9137741
• Report Number: 8010047-2019-03422
• Device Sequence Number: 2782215
• Product Code: GEI
• UDI-Device Identifier: 04953170343308
• UDI-Public: 04953170343308
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K111202
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 10/01/2019

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
• Operator of Device: Health Professional
• Device Model Number: TB-0920OE
• Device Lot Number: 67K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2019
• Initial Report FDA Received Date: 09/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1