MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SONOSURG STRAIGHT SCISSORS,HF,PISTOL GRIP,5MM X 34CM; ULTRASONIC SURGICAL DEVICE

Model Number	T3900
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to the service center for evaluation.A visual inspection was performed on the received device; the t3900 sonosurg scissors was received with the probe within the handle.The probe was removed from the handle and verified both the probe and handle had matching serial numbers (b)(4).There was foreign material observed, consistent with use.Approximately 17.5mm of the probe tip was detached at the distal end.The detached probe tip was not returned along with the device and is suspected to be missing.Further inspection found burnt marks on the insulated grasping surface; however, no metal was exposed.The burn marks are consistent with an increased temperature.The consistency of movement of the handle and jaw is normal.Based on the evaluation, the root cause to the reported complaint is attributed to user mishandling.
Event or Problem Description
The service center was informed that during a therapeutic appendectomy procedure, the probe tip broke off and fell inside the patient.The device fragments were retrieved from the patient.There was no report of bleeding.The intended procedure was completed with a similar device.No other equipment was replaced during the procedure.There was no patient injury reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to report the device evaluation results.The device was returned to service center for evaluation.A visual inspection was performed on the received device; the t3900 sonosurg scissors was received with the probe within the handle.The probe was removed from the handle and verified both the probe and handle have matching serial numbers (b)(6).Foreign material was observed, consistent with use.Approximately 17.5mm of the probe tip is detached from the distal end.The detached probe tip was not returned along with the device and is suspected to be missing.Burn marks of the insulated grasping surface was noted.However, no metal exposed.The burn marks are consistent with increased temperature.Based on the evaluation, the root cause to the reported complaint is attributed to user mishandling.

• Brand Name: SONOSURG STRAIGHT SCISSORS,HF,PISTOL GRIP,5MM X 34CM
• 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: 8896328
• Report Number: 8010047-2019-02938
• Device Sequence Number: 1617588
• Product Code: LFL
• UDI-Device Identifier: 04953170234941
• UDI-Public: 04953170234941
• Combination Product (Y/N): N
• PMA/510(K) Number: K050885
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2019

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: T3900
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 09/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1