MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH SAFEVIEW FO SU BLADE, MAC 4; LARYNGOSCOPE, RIGID

Model Number IPN915600

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2023

Event Type  malfunction  

Event Description

It was reported that " during the insertion of the blade in the throat the blade broke at the level of the green plastic connection.Additional information: patient consequence was that there was a delay in the procedure as they had to try other blades.The entire blade was removed with no part left in the patient.It is reported that the patient is deceased but not as a cause of the incident.2 blades broke.Associated complaints 9681900-2023-00030,and 9681900-2023-00029.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn#(b)(4).Three samples were returned to the manufacturer for investigation.The manufacturer reported: "although the defective samples are received "disinfected not to be considered sterile" but the returned blades were still contaminated.We thoroughly rinsed the returned samples under tap water and disinfected them.The device was visually inspected.The lip of the heel is broken on 2 of the returned samples.The engagement lock was found to be properly intact.Keeping in view above stated investigations it is revealed that the end user has not engaged blade properly onto the handle which resulted in breakage of lip in the foot part during application of force while using the blade.If the heel had been broken due to application of load then, engagement lock must had been broken but it is still there which shows that the blade was not properly engaged.Out of three of the returned samples, 2 were found that the lip of the foot part in blades was broken.We further reviewed the complaint history of the similar nature complaint.The root cause was determined to be user error."teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that " during the insertion of the blade in the throat the blade broke at the level of the green plastic connection.Additional information: patient consequence was that there was a delay in the procedure as they had to try other blades.The entire blade was removed with no part left in the patient.It is reported that the patient is deceased but not as a cause of the incident.2 blades broke.Associated complaints 9681900-2023-00030, 9681900-2023-00031 and 9681900-2023-00029.

• Brand Name: RUSCH SAFEVIEW FO SU BLADE, MAC 4
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer Contact: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18389915
• MDR Text Key: 331518259
• Report Number: 9681900-2023-00031
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN915600
• Device Catalogue Number: 670150-100040
• Device Lot Number: AZV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED