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

Model Number	E2515
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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 chest thorascopy, the pencil became defective wherein the tip fell out.Analysis of the photo provided showed that the tip of the pencil was re-attached.There was no patient injury.There was no further information available.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
This report is based on information provided by the global complaint handling system.The product was not returned; however, a picture was provided by the customer for analysis.The product in the picture appeared to have met the specification.The picture showed a pencil with an electrode inserted.The reported condition was not confirmed.The investigation found the pencil had the electrode inserted in it.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: 9943312
• Report Number: 1717344-2020-00422
• Device Sequence Number: 19558299
• Product Code: GEI
• UDI-Device Identifier: 10884524000497
• UDI-Public: 10884524000497
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K813071
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2020

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: E2515
• Device Catalogue Number: E2515
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 04/09/2020; 04/23/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 04/14/2020; 05/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1