MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLITE DISP MTL MAC 2; LARYNGOSCOPE, RIGID

Model Number IPN923883

Device Problem Fitting Problem (2183)

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

Event Date 08/09/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Other remarks: n/a.Corrected data: n/a.

Event Description

Reported as "blades in the new design are movable.They don't fit properly on the handle".The report states that "the event took place during the procedure.While feeding the laryngoscope, the spoon fell to the ground.The patient was not injured.No additional intervention was necessary.Another laryngoscope blade was used to intubate the patient".The patient status is reported as "fine".

Event Description

Reported as "blades in the new design are movable.They don't fit properly on the handle".The report states that "the event took place during the procedure.While feeding the laryngoscope, the spoon fell to the ground.The patient was not injured.No additional intervention was necessary.Another laryngoscope blade was used to intubate the patient".The patient status is reported as "fine".

Manufacturer Narrative

Qn#(b)(4).The complaint sample was not returned.The manufacturing site, truphatek, reported: "the complaints of "blade not holding on handle" for rusch greenlite disp mtl mac 3 products cannot be confirmed as there is no actual complaint device returned at site for physical investigation and without physical complaint devices actual root cause could not be determined.We did perform the dhr based investigation for the lot code 230505331 and the device history record for lot 2j0323 was reviewed and no issue that could have contributed to the reported failure was noted.The devices were manufactured according to the release specifications.Dhr record result shows the device was tested 100% for functional testing prior to ship to customer.The root cause of this complaint is deemed to be "undetermined /unknown" because there are no actual complaint devices returned for physical investigation.In the event if complaint devices will be made available for physical investigation, then this complaint file will be re-opened to document the actual findings based on the physical investigation." other remarks: n/a.Corrected data: n/a.

• Brand Name: RUSCH GREENLITE DISP MTL MAC 2
• 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: mariah mackinnon ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17606762
• MDR Text Key: 321775775
• Report Number: 8030121-2023-00017
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026704663115
• UDI-Public: 14026704663115
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/09/2023

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: Health Professional
• Device Model Number: IPN923883
• Device Catalogue Number: 004551003
• Device Lot Number: 230505331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/09/2023
• Initial Date FDA Received: 08/23/2023
• Supplement Dates Manufacturer Received: 09/27/2023
• Supplement Dates FDA Received: 10/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2023
• 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