MAUDE Adverse Event Report: GYRUS ACMI INC BIPOLAR PK WORKING ELEMENT

Model Number EIWE-BRPK

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 06/04/2014

Event Type  Injury  

Event Description

The user facility reported that during an unspecified procedure, the user received a shock while using the working element to perform the coagulation function of the device with a sp generator.No pt injury was reported.It is unk if the procedure was completed.Olympus attempted multiple times to f/u with the user facility, however, no further info was obtained.If new info is received at a later date this report will be supplemented.

Manufacturer Narrative

The device referenced in this report was not returned to olympus for eval.The exact cause of the reported event could not be determine.If add'l info is received at a later time, this report will be supplemented.

• Brand Name: BIPOLAR PK WORKING ELEMENT
• Type of Device: WORKING ELEMENT
• Manufacturer (Section D): GYRUS ACMI INC; 136 turnpike rd; southborough MA 01772 210
• Manufacturer (Section G): GYRUS ACMI INC; 136 turnpike rd; southborough MA 01772 210
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355002
• MDR Report Key: 3940221
• MDR Text Key: 4603795
• Report Number: 2951238-2014-00244
• Device Sequence Number: 1
• Product Code: FDC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EIWE-BRPK
• Device Catalogue Number: EIWE-BRPK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: (B)(4) SP GENERATOR, 2951238-2014-00242
• Patient Outcome(s): Other