DILATOR, 5.1 X 210MM
Received Aug 5, 2024 · Event occurred Jun 26, 2024
Report 1220246-2024-07029 · MDR key 19907594
Device
Generic name
Dilator
Manufacturer
Arthrex, Inc.Model number
DILATOR, 5.1 X 210MMCatalog number
AR-S6524-051-210
Lot number
UNK
Product problems
- Defective Device
- Defective Device
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
Description of Event or Problem
ON 07/09/2024, A SALES REPRESENTATIVE REPORTED VIA (B)(4) THAT AN AR-S6524-051-210 DILATOR HAD A PIECE OF METAL FROM THE INNER CANNULATION THAT STOPPED IT FROM GOING OVER THE SECOND SEQUENTIAL DILATOR. THERE WERE NO ADVERSE EFFECTS ON THE PATIENT AND THE CASE WAS COMPLETED SUCCESSFULLY. THIS WAS DISCOVERED DURING AN ENDOSCOPIC DISCECTOMY PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO MISUSE/MISHANDLING DUE TO DAMAGE TO THE DEVICE.