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

Model Number	E7509-B
Medical Device Problem Codes	Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary one device was received for evaluation.The returned product did not meet specification as received.Visual inspection found no defects.The investigation of the returned equipment did not identify anything that would have caused or contributed to the reported event.The investigation found that the electrode was removed out of the pouch.The electrode was detected by the generator.The polyhesive gel covering the electrode surface was relatively dry to the touch.The pads were assembled correctly.Continuity was checked with satisfactory results.The pads failed erit testing, because the gel was dry.Moisture loss occurs as soon as the pad is removed from the pouch.The investigation could not determine the root cause of the customer's report.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 device was used when patient had burn to abdomen site.No further information available at this time.

• 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: 8414366
• Report Number: 1717344-2019-00319
• Device Sequence Number: 1811262
• Product Code: GEI
• UDI-Device Identifier: 30884524001016
• UDI-Public: 30884524001016
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K861036
• 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
• Report Date (Section B): 03/12/2019

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 Model Number: E7509-B
• Device Catalogue Number: E7509-B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 03/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR