MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH EQUIPLED BLADEMAC 3; LARYNGOSCOPE, RIGID

Catalog Number 5843

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/26/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "according to customer complaint, can't be mounted on the handle (doesn't fix on the laryngoscope handle).The failure have been discovered before intubation, the devices has been replaced and procedure completed as planned.".

Manufacturer Narrative

Qn#(b)(4).The sample was returned and sent to the manufacturing site for investigation.The manufacturer reports no problems were found with the blade during engagement with the handle.The blade was tested with two different kinds of handles to confirm the locking and unlocking of the blade and no issues were encountered.The blade was found to be within specification.The device history record was reviewed for the lot number reported and no issues that could have contributed to the reported failure were noted.The device was manufactured according to release specification.The complaint cannot be confirmed.

Event Description

It was reported that "according to customer complaint, can't be mounted on the handle (doesn't fix on the laryngoscope handle).The failure have been discovered before intubation, the devices has been replaced and procedure completed as planned.".

• Brand Name: RUSCH EQUIPLED BLADEMAC 3
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 10393399
• MDR Text Key: 202581112
• Report Number: 8030121-2020-00141
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 07/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5843
• Device Lot Number: 200101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Initial Date Manufacturer Received: 07/26/2020
• Initial Date FDA Received: 08/11/2020
• Supplement Dates Manufacturer Received: 09/10/2020
• Supplement Dates FDA Received: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED