MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTS CORP. RICHARD WOLF MOTORIZED HAND PIECE INDEX 1; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Model Number 8564.021

Device Problems Device Reprocessing Problem (1091); Failure to Clean Adequately (4048)

Patient Problem Insufficient Information (4580)

Event Date 02/07/2023

Event Type  malfunction  

Event Description

Two design styles received from the company with the same product number 8564.021 with distinct internal design differences that are not indicated in the instructions for cleaning.The design differences impacted cleaning outcomes.Design style #1 retained tissue in internal crevices and design style #2 has an open mechanical space.Cleaning instructions for the internal openings not included in ifu.Both design styles were not accessible by routine- the routine cleaning tools recommended in the ifu (brushes and pressurized water).In design style #1, the cleaning tools packed tissue deeper into crevices.Brush model #7970404 recommended for cleaning the 5mm channel/valve is too small to contact all surfaces.Per section 8.6.7 of the ifu accessories for reprocessing, brush model #7970404 is indicated for channels 2.6-3.6mm.Style #1 was returned to the company due to not being able to remove the tissue from the device when following the ifu for cleaning.

• Brand Name: RICHARD WOLF MOTORIZED HAND PIECE INDEX 1
• Type of Device: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS CORP.; 353 corporate woods pkwy; vernon hills IL 60061
• MDR Report Key: 16477559
• MDR Text Key: 310626803
• Report Number: 16477559
• Device Sequence Number: 1
• Product Code: GEY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8564.021
• Device Catalogue Number: 8564.021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/21/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1