MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	E2781R-28ASP
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of initial report: (b)(6) 2017.One used e2781r-28asp electrode was received, and evaluation of the sample confirmed the issue with a fractured tip.Visual inspection found the tip was damaged.A piece had broken off and was returned with the device.Further examination of the tip under magnification also found stress fractures.The investigation identified the root cause of the reported event to be from applying excessive force to the electrode tip during use.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 during the procedure, the spatula tip broke easily without any tension applied to it.The piece fell into the cavity and was retrieved.A new device was used to continue.There was no patient harm.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 6761451
• Report Number: 1717344-2017-05657
• Device Sequence Number: 10913626
• Product Code: GEI
• UDI-Device Identifier: 20884524000708
• UDI-Public: 20884524000708
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K944244
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/05/2017

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: 10/05/2021
• Device Model Number: E2781R-28ASP
• Device Catalogue Number: E2781R-28ASP
• Device Lot Number: 62800127X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2017
• Initial Report FDA Received Date: 08/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1