MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLED FIBER OPTIC HANDLE, MEDIUM; LARYNGOSCOPE, RIGID

Catalog Number 133300

Device Problem Failure to Disconnect (2541)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Customer reported the blade used was not a teleflex product.

Event Description

Customer reported "it is very difficult or not possible to detach the blade from the handle".Reported issue occured prior to patient use during preparation of anesthesia.

Manufacturer Narrative

(b)(4).The sample was returned and sent to the manufacturer for evaluation.The manufacturer reports they performed an inspection on the handle head to confirm the width, which may contribute to tight issues with the blade; however, the width of the handle head was within specification.Heavy damages were observed near the slot area on the handle head due to the second ball bearing of the blade which had a damaged surface resulting in the tight issue with the blade and handle.A device history record review was performed and no relevant findings were identified.The manufacturer also reports that from a dimensional inspection, the product was conforming to the design specification.The slot on the head of the handle was found damaged which could be due to damage of the ball on the blade used for engagement.The handle was tested with a teleflex laryngoscope and was working fine.The root cause of the issue was determined to be user related.

Event Description

Customer reported "it is very difficult or not possible to detach the blade from the handle".Reported issue occured prior to patient use during preparation of anesthesia.

• Brand Name: RUSCH GREENLED FIBER OPTIC HANDLE, MEDIUM
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 9191998
• MDR Text Key: 189445796
• Report Number: 8030121-2019-00102
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/23/2019

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 Expiration Date: 04/02/2024
• Device Catalogue Number: 133300
• Device Lot Number: 190401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Initial Date Manufacturer Received: 09/23/2019
• Initial Date FDA Received: 10/15/2019
• Supplement Dates Manufacturer Received: 11/12/2019
• Supplement Dates FDA Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLADE; BLADE