MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH DISPOGRIP SU STD HANDLE

Catalog Number 88800

Device Problem Optical Problem (3001)

Patient Problem No Patient Involvement (2645)

Event Date 11/03/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#:(b)(4).

Event Description

The complaint is reported as: "the light flickers or goes out completely." the issue was detected prior to use on the patient.

Event Description

The complaint is reported as: "the light flickers or goes out completely." the issue was detected prior to use on the patient.

Manufacturer Narrative

Qn#(b)(4).The customer returned one rusch dispogrip single use standard handle and a mac 3 blade.Upon receipt, the blade and handle were visually inspected.No obvious signs of damage were observed.Both contact points on the blade and handle were intact.An r & d engineer measured the dimensions that would directly impact this feature and they all seem to be within specification.The returned blade and rusch dispoled handle were assembled to functionally test.The blade was connected to the handle without any resistance and was engaged.No flickering was observed when connected to a lab inventory handle.When force was placed on the blade the light flickered, for this reason the blade was sent to an r & d engineer for further inspection.They found that when force was placed on the blade in an upward direction (direction force is applied during intubation) the light did not flicker.Since the requirement of no flickering is in the upward direction only, flickering may be observed if a downward force is applied to the blade.They functionally tested the complaint blade with a known good lab inventory handle and the light did not flicker when force was placed on the blade in an upward direction.They also functionally tested the complaint handle with a known good lab inventory blade and the light did not flicker when force was placed on the blade in an upward direction.R & d also noted , "the user might have thought the blade was fully engaged but it was indeed not and therefore the flickering was noticed." the manufacturing dhr file was reviewed.No recorded results of manufacturing issues or anomalies were reported.The complaint was confirmed.The blade would flicker if not fully engaged or if force was applied to the blade in a downward direction.The root cause of this defect is user error.No further action required.

• Brand Name: RUSCH DISPOGRIP SU STD HANDLE
• Type of Device: DISPOGRIP
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 10869947
• MDR Text Key: 217463830
• Report Number: 3011137372-2020-00252
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/12/2022
• Device Catalogue Number: 88800
• Device Lot Number: 1906051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: RUSCH EQUIPLITE BLADE, MAC 3; RUSCH EQUIPLITE BLADE, MAC 3