MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH EQUIPLED BLADEMAC 4; LARYNGOSCOPE, RIGID

Catalog Number 5844

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 "sample associated with (b)(4) was received in the stuck condition on handle, further we have investigated and it has been identified that there was deep dent on the steel ball of blade and we noticed that handle groove are worn-out which may cause to stuck-up and poor compatibility issues of blade onto handle.We are suspecting that due to multiple use and due to inadequate handling of blade or either due to wrong handle application on blade there is possibility that deep dent mark can come on the steel ball.On the basis of investigation of physical sample, we can state that this is not a manufacturing defect, looking on the physical sample it seems that there was something wrong happened with blade because generally this kind of dent will not come on the steel ball and it is very difficult to identify that from where and how this dent mark projected on the steel ball.There can be many causes for this defect, it may be because of the inappropriate handling, it may be because of the contact with the hardened material, or it may be because of the wrong handle application." the device history record was reviewed for lot number reported and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.

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 4
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 10393410
• MDR Text Key: 202588823
• Report Number: 8030121-2020-00140
• 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: 5844
• Device Lot Number: UNKNOWN
• 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