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

Model Number	E7507-DB
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/28/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during the procedure, the return electrode monitoring (rem) pad would not work.Green rem light would be visible on the electrosurgical unit, but the devices would not show any clinical effect.Nurse replaced the pad with another similar pad and everything worked fine.There was no patient injury.
Additional Manufacturer Narrative
Additional information: evaluation summary: two devices were received for evaluation.The returned product did not meet specification as received.Visual inspection found no defects on both pads.The reported condition was confirmed.The investigation found the gel covers to have been removed and the devices were received in open packaging.The polyhesive gel covering the electrode surface was dry to the touch.The pad was assembled correctly.Continuity was checked with satisfactory results.The pad failed erit testing, and during impedance testing the return electrode monitoring (rem) alarm sounded.This is a designed safety feature that would occur if the gel had dried out, it therefore functioned as intended.The rem feature of the return electrode operates by measuring the electrical impedance at the return site.Should this impedance vary beyond an established level, the rem alarm will sound, and the generator will shut down.Moisture loss occurs as soon as the pad is removed from the pouch.The investigation cannot determine if the pad was dry when the customer applied it to the patient during the procedure.The investigation could not determine the root cause of the customer's report.Refer to the instruction for use (ifu) for recommendations on pad application and placement.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: 8038018
• Report Number: 1717344-2018-01439
• Device Sequence Number: 19198774
• Product Code: GEI
• UDI-Device Identifier: 10884524000602
• UDI-Public: 10884524000602
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K822572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2019

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: 01/03/2020
• Device Model Number: E7507-DB
• Device Catalogue Number: E7507-DB
• Device Lot Number: 73520531X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 11/05/2018
• Supplement Report FDA Received Date: 01/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1