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 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "client used mri kit 005852300 and mill 2 blade jammed on the handle and cannot be removed".No patient involvement reported.

Event Description

It was reported "client used mri kit 005852300 and mill 2 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 7 varying blades and one handle.The handles were visually inspected for signs of abuse/misuse/damage, nothing was found.One miller 2 blade was returned on the handle.The miller 2 blade was removed from the returned handle with more than normal force required.Three different lab inventory blades (rusch miller 3, rusch mac 1, focs mac 4) were able to be engaged and disengaged from the returned handle without any unusual resistance or unusual force to disengage them.The retuned miller 2 blade was able to be engaged and disengaged on the returned handle without any unusual resistance once it was initially removed from the handle.The other six blades were not able to be connected to the returned handle initially, because their ball bearings were too stiff.After applying a great amount of force, all six blades were able to be attached to the handle, engaged and disengaged.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, "clean and dry blades and handles thoroughly before storage".The complaint was confirmed via functional inspection.All 7 of the returned blades had stiff ball bearings making it difficult to attach them to their handle.The root cause of this failure is unknown.It is possible that the blade set was stored in a high humidity environment.The ball bearings can also become stiff if they are not dried properly after sterilization, but since the customer stated that this kit was new, this option is unlikely.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: 11225999
• MDR Text Key: 228971047
• Report Number: 8030121-2021-00001
• 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: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• 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: 200801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1