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

Model Number	E2750
Medical Device Problem Code	Device Remains Activated (1525)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/24/2017
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.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that during the procedure, when coag was activated the button did not return smoothly.A new device was opened to continue the procedure.There was no patient harm.
Additional Manufacturer Narrative
The incident pencil was visually inspected and functionally tested and no failure was identified.The pencil functioned normally and within specifications.No conditions were identified that would have caused or contributed to the reported failure.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that during the procedure, when coag was activated the button did not return smoothly.A new device was opened to continue the procedure.There was no patient harm.

• 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: 6414649
• Report Number: 1717344-2017-05111
• Device Sequence Number: 10775081
• Product Code: GEI
• UDI-Device Identifier: 20884524000432
• UDI-Public: 20884524000432
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K964175
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2017

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: 09/22/2021
• Device Model Number: E2750
• Device Catalogue Number: E2750
• Device Lot Number: 62670122X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/24/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2017
• Supplement Report FDA Received Date: 05/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1