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

Model Number	E2401
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Radiation Exposure, Unintended (3164)
Date of Event	09/18/2018
Type of Reportable Event	Serious Injury
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 use, when the piece of the tip cleaner in half was cut, a trace of the marker was detected in the patient through an x-ray.
Additional Manufacturer Narrative
Evaluation summary: the product was not returned; however, a picture was provided by the customer for analysis.It could not be determined if the product in the picture meet specification.The picture showed the tip cleaner and a blue strand.Without the product a detailed investigation could not be performed.If additional information is obtained, or the product is returned, we will re-open this investigation.This reported complaint is off label use of the device tip cleaner.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during use in video-assisted thoracoscopic surgery (vats) wedge resection, the piece of the tip cleaner was cut in half, a trace of the marker was detected in the patient through an x-ray.The piece of the scratch pad was used for mechanical pleurodesis of the lung.Planned post op x-ray routine was done.No future operation or intervention was needed due to the retained piece of scratch pad in the thoracic cavity.The patient was stable and discharged.

• 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: 7979091
• Report Number: 1717344-2018-01366
• Device Sequence Number: 13710529
• Product Code: GEI
• UDI-Device Identifier: 30884524001825
• UDI-Public: 30884524001825
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K882646
• 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
• Report Date (Section B): 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: E2401
• Device Catalogue Number: E2401
• Device Lot Number: 42881836X
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 12/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention