MAUDE Adverse Event Report: GYRUS ACMI, INC IGLESIAS WORKING ELEMENT

Model Number EIWE

Device Problems Sparking (2595); Flare or Flash (2942)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2017

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus for evaluation.The cause of the reported event cannot be determined.

Event Description

Olympus was informed that during an unspecified procedure, the surgeon heard a sizzle sound and observed a flash / spark from the working element.The procedure was completed with a different device.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to report the device evaluation results and provide the device manufacture date the device was returned to olympus for evaluation.A visual inspection was performed on the returned device and found charring deposits inside the actuation block and the red dot on the release button was missing.The customer¿s working element was then checked with the following test equipment: model: mle-24-015 electrode, dac active cord and esg-400 generator.There was no sizzle sound, flash, or sparking was observed during activation.The working element was tested for leakage and failed from the lock body and tube assembly area.However, its mechanism parts are working properly.Based on the investigation results, the device failed the leak test; therefore, if moisture was inside the actuation block where the electrode proximal end locks in with the dac connector an intermittent connection would produce the sparking or arching once the output is activated.

• Brand Name: IGLESIAS WORKING ELEMENT
• Type of Device: IGLESIAS WORKING ELEMENT
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6706794
• MDR Text Key: 79918496
• Report Number: 2951238-2017-00451
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK951972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2017

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: EIWE
• Device Catalogue Number: EIWE
• Device Lot Number: UNKNOWN
• Other Device ID Number: UDI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/23/2017
• Initial Date FDA Received: 07/12/2017
• Supplement Dates Manufacturer Received: 08/07/2017
• Supplement Dates FDA Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1