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	03/24/2017
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.
Event or Problem Description
The customer reported the during the procedure the spatula tip broke and fell into the patient's cavity.The tip was immediately removed from the patient and a new device was used to continue.There was no harm to the patient.
Additional Manufacturer Narrative
One (b)(4) was received for evaluation.Visual inspection found the tip of the electrode to have broken off.The investigation found the tip had broken off.The broken tip was returned.The broken tip was inspected under magnification and found to have stress fractures.The investigation identified the root cause of the reported event to be the user applying excessive force to the electrode tip.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 the during the procedure the spatula tip broke and fell into the patient's cavity.The tip was immediately removed from the patient and a new device was used to continue.There was no harm to the patient.

• 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: 6494594
• Report Number: 1717344-2017-05221
• Device Sequence Number: 16479975
• 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,Followup
• Report Date (Section B): 05/01/2017

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: 10/13/2021
• Device Model Number: E2781R-28ASP
• Device Catalogue Number: E2781R-28ASP
• Device Lot Number: 62410137X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2017
• Supplement Report FDA Received Date: 05/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1