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

Model Number	E2516HS
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/25/2018
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 a procedure, the device broke in two pieces.Nothing fell into patient cavity.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance led an investigation into the reported complaint in conjunction with engineering.One device was received for evaluation.This device had been used in the treatment or diagnosis of a patient.Without the original packaging or a reported lot number, the investigator cannot determine if the product was within the assigned expiration date at the time of reported incident.The returned product did not meet specification as received.Visual inspection found that the device was separated into halves at the ultrasonic bond.The reported condition was confirmed.The investigation found that the device separated into two halves along the ultrasonic bond line.Engineering confirmed pencil housings were un-welded.There is no lot number.Without the lot number there is no record of when produced and therefore no further research of the record possible.There are two procedures in place to identify an under-welded pencil.The welding equipment is programmed with minimum energy limits and alarms the under welded condition to alert operator.Also, product is 100% visually inspected for quality.This pencil was accepted with insufficient weld strength.This pencil should have been rejected by the welder and operator.A weak weld is isolated and rare.The pencil was not used in a procedure.The investigation identified the root cause of the reported event to be manufacturing.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 7674449
• Report Number: 1717344-2018-00914
• Device Sequence Number: 2643248
• Product Code: GEI
• UDI-Device Identifier: 10884524001500
• UDI-Public: 10884524001500
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K945260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 10/05/2018

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: E2516HS
• Device Catalogue Number: E2516HS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2018
• Initial Date Received by Manufacturer: 06/25/2018
• Supplement Date Received by Manufacturer: 07/19/2018; 08/21/2018; 08/08/2018; 08/08/2018
• Initial Report FDA Received Date: 07/10/2018
• Supplement Report FDA Received Date: 08/08/2018; 09/07/2018; 10/03/2018; 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1