MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH EMERALD FO MACINTOSH BLADE; LARYNGOSCOPE, RIGID

Model Number IPN049940

Device Problem Physical Resistance/Sticking (4012)

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

Event Date 02/05/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A review of video sent by the customer was completed and observed the blade fitting properly on the handle.It was also observed that the customer placed the blade from off to on position, however it cannot be determined in the video if the customer is trying to remove the blade from the handle from the on position or if the customer is trying to change the position of the blade to off position.An additional test was conducted, and 4 samples were taken from the current warehouse stock (004433300hrm blade batch # jrr).The samples were visually inspected, for confirmation of good packaging and blade condition.No issues observed during visual inspection.A device history record review was not conducted since the lot number was not provided.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

It was reported "customer called with complaint of blade not fitting properly onto the handle.I went onsite and was able to determine that only the mac size 3 blades were having issues.They would snap on, but then they would get stuck onto the handle and not release unless extreme force was used.The were also at times very difficult to snap onto the handle.The miller blades did not cause any issues which led me to believe that it was only a mac blade issue and not a handle issue".No patient injury or harm reported.Patient condition reported as "fine".

Event Description

It was reported "customer called with complaint of blade not fitting properly onto the handle.I went onsite and was able to determine that only the mac size 3 blades were having issues.They would snap on, but then they would get stuck onto the handle and not release unless extreme force was used.The were also at times very difficult to snap onto the handle.The miller blades did not cause any issues which led me to believe that it was only a mac blade issue and not a handle issue".No patient injury or harm reported.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4) the customer provided a video for investigation.The video shows the customer is having difficulty removing the blade from the rusch green spex handle.The customer also returned one 004433300 emerald fo macintosh blade for investigation.Upon receipt, the blade was visually examined.No defects or anomalies were observed.Functional inspection was performed to recreate the product's intended use.The ifu provided with this product states the following: "attach blade to compatible handle.Click into place." "to switch on, pull blade up" "to switch off, fold blade down" "return to off position after use." in an attempt to simulate the defect shown in the customer video, the returned blade was attached to a rusch green spex handle.However, the blade did not get stuck on the handle.The blade was able to be easily attached and removed from the handle.Next, the returned blade was attached to a lab inventory rusch medium fo handle, green led handle and green spex handle.The led functioned properly when attached to each lab inventory handle.The blade was then removed from the handle with no difficulty.A lab inventory polaris rusch miller 2 blade and emerald rusch miller 2 blade was then attached to the same three handles.There was no significant difference noted in how easily the lab inventory blades were able to be removed from the handles, when compared to the returned blade.Manufacturing performed additional tests for this complaint investigation.There were 4 ea blades of part number 004433300hrm in the warehouse.This part number is used to build product code 004433300; the blades found were requested from the warehouse to run additional tests.The batch of the requested material is jrr.The requested material is in good packaging and visual condition, in conclusion no discrepancies are detected in the blade conditions.Additional tests were performed with 3 different handles for each blade, the handles used are compatible with the 004433300hrm blade.Additional tests were performed as indicated in the ifu operating instructions.No functional failures were detected and there were no difficulties in removing the blades from the handles.The reported complaint of "blade stuck on handle during use" could not be confirmed.There were no issues found with the returned blade.Additional tests were performed on blades in stock at the manufacturing plant and the reported defect could not be replicated.A device history record review was performed with no evidence to suggest a manufacturing related cause.At the time of manufacturing assembly, all of the blades are 100% inspected and if a blade does not meet the quality criteria, it gets discarded.It is unlikely that a defect was present at the time of release.Based on the information available and without the handle returned for investigation, the root cause of this complaint could not be determined.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: RUSCH EMERALD FO MACINTOSH BLADE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11424082
• MDR Text Key: 259227863
• Report Number: 3011137372-2021-00048
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026704640260
• UDI-Public: 14026704640260
• 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: 02/11/2021

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 Model Number: IPN049940
• Device Catalogue Number: 004433300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2021
• Initial Date Manufacturer Received: 02/11/2021
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: 03/31/2021
• Supplement Dates FDA Received: 04/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HANDLE.; HANDLE.