MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH REUSABLE LARYNGOSCOPES; LARYNGOSCOPE, RIGID

Catalog Number 4211X

Device Problem Material Separation (1562)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2022

Event Type  Death  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "the fixing bar for attaching the laryngoscope blade detached when the handle was removed and was lost.Due to the absence of the fixation bridge, it was not possible to use it for laryngoscopy".Additional information stated "the problem occurred during the preparation of the laryngoscope, immediately before use on the patient and could not be used on the patient due to the defect".

Event Description

It was reported that "the fixing bar for attaching the laryngoscope blade detached when the handle was removed and was lost.Due to the absence of the fixation bridge, it was not possible to use it for laryngoscopy".Additional information stated "the problem occurred during the preparation of the laryngoscope, immediately before use on the patient and could not be used on the patient due to the defect".

Manufacturer Narrative

Qn#(b)(4).Additional information was requested for clarity regarding the event.It was reported that the illness of the patient was not known.The use of a second device was necessary, which caused a delay in the procedure.It was also reported that "the patient died in the hospital after the event.The patient was not injured, but a mechanical airway obstruction could not be ruled out initially." no further medical interventions were reported.The date of death was not reported.The initial information received indicates the event occurred during preparation and not during use on the patient, inferring the device was not contributory to the death of the patient; however additional information received conflicts original information by saying that "a mechanical airway obstruction could not be ruled out".Therefore a conservative decision has been made to update the type of event to "death" in the unlikely scenario that there may have been an association between the device issue and the death.The sample was returned and sent to the manufacturing facility for evaluation.The manufacturing site reports: "the actual complaint sample was delivered to the site to perform the investigation, the complaint sample was visually inspected by the chandigarh investigating team and the customer reported failure mode was verified and confirmed, i.E.The fixing bar for attaching the laryngoscope blade was missing and it detached from the handle.During visual inspection it was noted that the design of the current greenspec handle, and the complaint reported product is different." it was also reported that "visual inspection result showed that the fixing bar was missing in the complaint device and the groove of the handle was worn out on both sides.Further we did perform the dimensional inspection of the customer returned complaint sample for critical dimensions which could contribute for fixing bar detached issue.As per the dimensional inspection results of complaint sample, defective product was found acceptable for critical dimensions as per design /drawing and manufacturing release specifications.Dimensional inspection results showed parts are meeting the design spec and comply with iso-7376 requirements.We did perform the inspection of the handle head, and we received handle without fixing bar as it lost and not found as stated in notification summary, so we could not be able to confirm the fixing bar dimensions.There were design change history of material happen in 2010 where material of head changed from brass to stainless steel." the conclusion from the manufacturing site is as follows: "during investigation, the failure mode of fixing bar detached in the complaint device was confirmed and justified, but this is not a manufacturing defect because the truphatek reusable handle does have material warranty of 5 yrs.For material and manufacturing defect whereas in the reported complaint involved product was manufactured in 2005 based on the lot code information and customer used the complaint device more than the defined shelf life and at the time of complaint reported product was already exceeded the shelf life of 5 yrs.The root cause of this complaint is deemed user unintentional error, as the customer used the product beyond its material life of 5 yrs." the device has aged nearly 17 years as it was manufactured in 2005.Corrected data: section h.1.-type of event updated to 'death' section h.6.-health effect impact code corrected to 1802.

• Brand Name: RUSCH REUSABLE LARYNGOSCOPES
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TRUPHATEK INTERNATIONAL LTD.; 14 benny gaon street; p.o. 8051; netanya 42504 43; IS 4250443
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 13794337
• MDR Text Key: 292507123
• Report Number: 8030121-2022-00008
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2022

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 Catalogue Number: 4211X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/21/2022
• Initial Date FDA Received: 03/17/2022
• Supplement Dates Manufacturer Received: 04/07/2022
• Supplement Dates FDA Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: BLADE AND HANDLE; BLADE AND HANDLE
• Patient Outcome(s): Death