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

Model Number	E7506-
Medical Device Problem Code	Flare or Flash (2942)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample was requested but to date has not been received for evaluation.If the sample or additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that post procedure, the patient experienced a skin burn where one of the two grounding pads had been placed during the procedure.Topical treatment was applied.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Additional information: evaluation summary: the product was not returned; however, a picture was provided by the customer for analysis.From the provided information it can not be determined if the product met specification.The picture showed reddening on the skin of a patient at the pad site.No pictures of the device were provided for analysis.The customer reported condition was not confirmed.Without the product a detailed investigation could not be performed.If the sample or additional information pertinent to the incident is obtained, a follow-up report will be submitted.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: 6988499
• Report Number: 1717344-2017-06128
• Device Sequence Number: 118867
• Product Code: GEI
• UDI-Device Identifier: 20884524000982
• UDI-Public: 20884524000982
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K822572
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2017

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: 05/13/2019
• Device Model Number: E7506-
• Device Catalogue Number: E7506-
• Device Lot Number: 71320087X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 11/15/2017
• Initial Report FDA Received Date: 10/30/2017
• Supplement Report FDA Received Date: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1