MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. CHEST THORACOSCOPY PACK-BOVIE PENCIL ; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number CDS9847671

Device Problems Device Slipped (1584); Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/22/2020

Event Type  malfunction  

Event Description

Bovie pencil became defective during case and was unable to hold the cautery tip.Fda safety report id# (b)(4).

• Brand Name: CHEST THORACOSCOPY PACK-BOVIE PENCIL
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. ; northfield IL 60093
• MDR Report Key: 9641740
• MDR Text Key: 177159259
• Report Number: MW5092589
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/27/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: CDS9847671
• Device Lot Number: 19JBP915
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 93