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

Model Number IPN049940

Device Problem Use of Device Problem (1670)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2022

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be 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

Customer reported that: "the blades are getting stuck on the handle".No patient injury or consequence reported.Patient condition reported as "fine".

Event Description

Customer reported that: "the blades are getting stuck on the handle".No patient injury or consequence reported.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).Although a lot number was not provided, multiple potential lots were identified based on the sales history for this customer.The potential lots are 74e2100266, 74e2101046, 74g2100786, 74g2101514, 74g2102135, 74l2000292, and 74g2102135.The device history records of these lots have been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non-conformance reports were originated for the lots in question that can be associated to the complaint reported.Dhrs show that the product was assembled & inspected according to our specifications.The customer returned one emerald rusch mac 3 blade for evaluation.The blade was visually inspected for signs of abuse/misuse/damage.Small scratches were found adjacent to the ball bearing on the base of the blade which are indicative of normal wear.There were no significant scratches or burrs found on the ball bearings.Reference file anp1900094060 for investigation photos.A dimensional inspection was performed on the base of the blade with reference to product drawing dwg-ane-023.The blade was measured using a calibrated caliper (tfx id: ref-002640) along the length and width of the base.The length was measured to be 0.933" (23.698mm), which is within the specification of 23.3mm +/- 0.50mm.The width was measured to be 0.531" (13.487mm), which is within the specification of 13.35mm +/- 0.15mm.No defects no anomalies were observed during the dimensional analysis.The mac 3 blade was functionally tested with two different lab inventory handles (rusch greenspec and rusch polaris) per ifu l02267.The ifu states, "attach blade to handle.Click in place.To switch on, pull blade up.To switch off, move blade down." the blade was able to be connected to both lab inventory handles, engage, and then disengage with no issues.Additionally, the blade was tested with the handles from tc 20043355, which are associated with the device as they were reported during the same incidents.Reference tc 20043355 for complete details on the investigation of the returned handles.Multiple handles were tested from tc 20043355 with this blade and again no issues were found when attaching and detaching the blade.Multiple attempts were completed and there was no difficulty observed during testing.Reference file anp1900094060 for investigation photos.Therefore the complaint cannot be confirmed.Product drawing dwg-ane-023 was referenced for dimensional analysis.The ifu (l02267) states, "attach blade to handle.Click in place.To switch on, pull blade up.To switch off, move blade down." according to wi-ane-023, in a production order all of the blades are 100% inspected.If a blade does not meet the quality criteria, it will get discarded.The complaint cannot be confirmed.No defects or anomalies were oberved during visual, dimensional, or functional inspection.No cor rective/preventative actions will be assigned.The complaint cannot be confirmed.Visual inspection revealed small scratches adjacent to the ball bearing on the base of the blade which are indicative of normal wear.There were no significant scratches or burrs found on the ball bearings.No anomalies were observed during dimensional analysis.The blade was functionally tested with multiple lab inventory handles as well as the handles that were involved in the reported incidents.No functional issues were found.A dhr review was performed based on the sales history with no relevant findings identified.Therefore there was no fault found with the returned blade.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
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14836558
• MDR Text Key: 301344168
• Report Number: 3011137372-2022-00114
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026704640260
• UDI-Public: 14026704640260
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2022

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 Model Number: IPN049940
• Device Catalogue Number: 004433300
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2022
• Initial Date FDA Received: 06/27/2022
• Supplement Dates Manufacturer Received: 07/21/2022
• Supplement Dates FDA Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: HANDLE.; HANDLE.