MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH MRI SET: HDL+ MIL 1,2,3 MAC 2,3,4; LARYNGOSCOPE, RIGID

Model Number IPN048624

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 02/04/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported "client used mri kit 005852300 and blade jammed on the handle and cannot be removed".No patient involvement reported.

Event Description

It was reported "client used mri kit 005852300 and blade jammed on the handle and cannot be removed".No patient involvement reported.

Manufacturer Narrative

(b)(4), the customer returned one rusch mri set (005852300) containing 6 varying blades (mil 1, mil 2, mil 3 , mac 2, mac 3, mac 4) and one handle.The components were visually inspected for signs of abuse/misuse/damage and nothing was found.The mac 2 blade was returned on the handle.The blades in the kit were functionally tested per ifu l07085 rev.01 which states, "attach blade to handle.Click in place.To switch on, pull blade up.To switch off, move blade down." the mac 2 blade was not able to be removed from the returned handle.The other five other blades were able to be connected to a lab inventory rusch mri handle, engaged, and disengaged with no issues.R and d was consulted about the mac 2 blade stuck on the mri handle.They were able to remove the blade from the handle and found that both components passed the relevant dimensional inspections.They also found that the handle had sharp edges and deformation where the blade's ball bearings would engage.It is unknown what caused this damage.The device history record of lot 200801 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The instructions for use (ifu) provided with this kit instructs the user, "attach blade to handle.Click in place.To switch on, pull blade up.To switch off, move blade down." the complaint was confirmed via functional inspection.The returned mac 2 blade was found to be stuck on the mri handle.Once the handle was removed from the blade, the handle was found to have sharp edges and deformation where the blade's ball bearings would engage.The root cause of this failure is unknown.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: RUSCH MRI SET: HDL+ MIL 1,2,3 MAC 2,3,4
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11487299
• MDR Text Key: 240012047
• Report Number: 8030121-2021-00010
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026704616371
• UDI-Public: 14026704616371
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPN048624
• Device Catalogue Number: 005852300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1