MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NORTHFIELD MEDLINE CAUTERY HOLSTERS PATEWOOD MINOR PROCEDURE; GENERAL SURGERY TRAY

Lot Number 23BBE485

Device Problems Break (1069); Defective Component (2292); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2023

Event Type  malfunction  

Event Description

The holster for the cautery pencil in the patewood minor procedure (164170-minor) are faulty.The plastic piece that bends in order to attach the holster to sterile field breaks off when bent resulting in inability to attach holster to drapes/mayo/sterile field.This is packaged in a medline pack.Lot number provided below is for the pack since there is no individual lot number or manufacturer name on the actual holster.Multiple incidents have occurred.The two lot numbers that were saved are all from minor packs (lot # 23bbe485 and 23cbd530).Staff state that same issue occurs with the holster located in the fess (a53753-ent/fess) packs.When issue arose, email was sent to material manager and value analysis coordinator requesting the item be switched to a different bovie and holster.Reference reports: mw5117941, mw5117943.

• Brand Name: MEDLINE CAUTERY HOLSTERS PATEWOOD MINOR PROCEDURE
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NORTHFIELD
• MDR Report Key: 17019394
• MDR Text Key: 316221908
• Report Number: MW5117942
• Device Sequence Number: 1
• Product Code: LRO
• 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: 05/24/2023

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 Lot Number: 23BBE485
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/26/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other