MAUDE Adverse Event Report: NEW DEANTRONICS LTD VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	VL2610DB
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	12/20/2019
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 the procedure, a piece of plastic of scalpel was merged and part of it fell into the patient's cavity.The piece was fully retrieved.There was n no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.Visual inspection found scratches on the blade and the blue plastic injection part.No traces of melting.The scratches appear to be in the opposite direction of product assembly.The investigation by the supplier found scratches on the blade and the blue plastic injection part.No traces of melting.The scratches appear to be in the opposite direction of product assembly.The manufacturing process was examined and there in nothing in the process that would have caused the scratches.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, a piece of plastic of scalpel was merged and part of it fell into the patient's cavity but did not fully disengaged.The piece was also fully retrieved.There was no patient injury.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): NEW DEANTRONICS LTD; 12f no 51 sec 4 chong yang ro; taipei 23675 ; TW 23675
• MDR Report Key: 9546346
• Report Number: 1717344-2020-00014
• Device Sequence Number: 2283272
• Product Code: GEI
• UDI-Device Identifier: 10884521196681
• UDI-Public: 10884521196681
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K982743
• 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,Followup
• Report Date (Section B): 03/30/2020

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 Expiration Date: 06/30/2024
• Device Model Number: VL2610DB
• Device Catalogue Number: VL2610DB
• Device Lot Number: 1904144X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2020
• Initial Date Received by Manufacturer: 12/20/2019
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 03/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1