MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH TRUMRI HANDLE, MEDIUM; LARYNGOSCOPE, RIGID

Catalog Number 5525M

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 09/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample was not returned for evaluation at the time of this report.

Event Description

The customer alleges that the handle was attracted to the mri prior to patient use.

Manufacturer Narrative

(b)(4).The device history record was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The sample was returned for evaluation.The manufacturer then sent the sample on to an external consultant for evaluation in an mri room.The final report by the consultant shows this sample is well inside the defined acceptance levels based on astm f2052-15.Based on the evaluation by the external consultant, the complaint could not be confirmed.The cautionary information provided with the device indicates that the "devices are not intended for use during the operation of an mr system for an mr imaging procedure.The highest spatial gradient field of 720-gauss/cm".It was determined that the root cause is operational context as no issues were found with the returned device.

Event Description

The customer alleges that the handle was attracted to the mri prior to patient use.

• Brand Name: RUSCH TRUMRI HANDLE, MEDIUM
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5996298
• MDR Text Key: 56362171
• Report Number: 3011137372-2016-00297
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: WZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5525M
• Device Lot Number: 153601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1