MAUDE Adverse Event Report: BOVIE MEDICAL CORPORATION ES04; EXTENDED BLADE

Catalog Number	ES04
Medical Device Problem Code	Missing Value Reason (3192)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Defective pouch was found prior to use.No patient injury was reported.Complaint was not confirmed.No product was available for evaluation for es04 with sterile lot 0617a.Peel pouch label and the shelf box label also have statements that read: do not use if packaging is damaged or opened.Quality awareness training was performed 10-05-2017 for all applicable sealing personnel of the reported complaint.End user could not confirm the actual quantity of unsealed pouches.The cardinal health (b)(4) complaint states "the bag was not sealed" and says a sample is not available.Reached out with cardinal health (b)(4) and reporting hospital multiple times seeking verification of the complaint or quantity confirmed, they could not supply any additional information.Also, requested information about locating of the open seal (supplier seal or bovie's seal).No information was provided.A review of the device history record for sterile lot 0617a shows a quantity of (b)(4) pc was packaged with a 94 pc inspection sample.No failures were noted during the packaging or inspection process.A review of the device history record for sterile lot 0617a, shows no failures were noted during the packaging or inspection processes.A review of the receiving inspection history file for the raw materials (b)(4) show this lot passed the pull test sample check per sp-0735.A.Per sp-0735 the burst test was performed per qa-019 burst test procedure and fixture f100-2600.
Event or Problem Description
Customer alleged a bag that was not sealed.

• Brand Name: ES04
• Common Device Name: EXTENDED BLADE
• Manufacturer (Section D): BOVIE MEDICAL CORPORATION; 5115 ulmerton road; clearwater FL 33760 4004
• MDR Report Key: 6919282
• Report Number: 3007593903-2017-00007
• Device Sequence Number: 19193579
• Product Code: GEI
• UDI-Device Identifier: 10607151056046
• UDI-Public: (01)10607151056046
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K931338
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 10/05/2017

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: 06/01/2021
• Device Catalogue Number: ES04
• Device Lot Number: 0617A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other