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

Model Number	E2401
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
To date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.
Event or Problem Description
The customer reported the pads aren't sticking to the drape.They've had a couple tip cleaners go into the patient which the tech saw right away.The tip cleaner was retrieved without any injury to the patient.
Additional Manufacturer Narrative
The device associated with this issue was not returned for evaluation.However, two unopened devices of the same lot were returned, and evaluation of the samples could not confirm the reported issue.Visual inspection found no defects.The adhesive properties of the samples were tested on a variety of surfaces including surgical drapes, stainless-steel and plastic.The product was removed and re-positioned ten times with satisfactory results.The investigation found the returned devices to function normally and within specifications.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 MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 6494334
• Report Number: 1717344-2017-05216
• Device Sequence Number: 1201689
• Product Code: GEI
• UDI-Device Identifier: 30884524001825
• UDI-Public: 30884524001825
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K882646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2017

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: 07/20/2021
• Device Model Number: E2401
• Device Catalogue Number: E2401
• Device Lot Number: 42805940X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2017
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: 07/10/2017
• Initial Report FDA Received Date: 04/14/2017
• Supplement Report FDA Received Date: 08/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1