MAUDE Adverse Event Report: COVIDIEN MEDICAL PRODUCTS VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	E3310
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device has been received and is under evaluation.When the device evaluation is complete a follow-up report will be submitted.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that the junction between the insulation and the plastic hand piece broke during use on a patient.Prior to breaking, the device was reported to feel unstable.No piece of the device fell within the patient.There was no patient injury, and a new device was used to continue the procedure.
Additional Manufacturer Narrative
Evaluation summary: one used e3310 device was received, and examination of the sample confirmed an issue with a detached component.Visual inspection found the shaft was bent and had detached from the body of the device.No pieces were missing, and the device failed hipot testing for electrical leakage at the point where the shaft connects.This type of damage can be caused by bending the shaft during use.The investigation identified the root cause of the reported issue to be mishandling.The instructions included with this product cautions users that applying excessive force, kinking, or bending at severe angles may result in damage to the device.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MEDICAL PRODUCTS; building 10- no 789 puxing roa; shanghai 20111 4; CN 201114
• MDR Report Key: 6816056
• Report Number: 3006451981-2017-05531
• Device Sequence Number: 149879
• Product Code: GEI
• UDI-Device Identifier: 10884524002040
• UDI-Public: 10884524002040
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K091223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2017

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/07/2021
• Device Model Number: E3310
• Device Catalogue Number: E3310
• Device Lot Number: S6DE008X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2017
• Initial Date Received by Manufacturer: 07/29/2017
• Supplement Date Received by Manufacturer: 09/06/2017
• Initial Report FDA Received Date: 08/24/2017
• Supplement Report FDA Received Date: 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1