MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION SONOSURG SCISSOR, 5MM OD, HF SERIES; ULTRASONIC SURGICAL DEVICE

Model Number T3070

Device Problem Loss of Power (1475)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that during a laparoscopic procedure, no power was observed when cutting tissue.In an attempt to complete the procedure with the same device, the device was removed from the patient and cleaned.It was reported that it was reconnected and the power was unable to be restored.The procedure was completed with a non-olympus device.There was no patient injury reported.No additional information was provided.

Manufacturer Narrative

The device referenced in this report was returned to olympus for evaluation.The reported event of a loss of power was confirmed.It was noted that the teflon pad was burned.It was observed that the tip of the probe was chipped.The device was sent to the original equipment manufacturer (oem) for further evaluation.The oem confirmed the reported event.

• Brand Name: SONOSURG SCISSOR, 5MM OD, HF SERIES
• Type of Device: ULTRASONIC SURGICAL DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORPORATION; 2951 ishikawa-cho; hachioji-shi; tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131-1700 ; 4089355002
• MDR Report Key: 4360869
• MDR Text Key: 19347503
• Report Number: 2951238-2014-00593
• Device Sequence Number: 1
• Product Code: LFL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972114
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/06/2001

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
• Device Operator: Health Professional
• Device Model Number: T3070
• Device Catalogue Number: T3070
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/08/2001
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/06/2001
• Initial Date FDA Received: 12/19/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1