MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLITE DISP MTL MAC 4; LARYNGOSCOPE, RIGID

Model Number IPN048387

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint reported as: while using a laryngoscope blade during a life-saving emergency, the plastic base part of the laryngoscope blade broke in the handle.Clinical consequences: successful intubation with this broken blade but risk for the patient.No loss part in the patient.

Manufacturer Narrative

(b)(4).Corrected data: section d.4.-lot# corrected to 1906341.The sample was received and returned to the manufacturing site for evaluation.The manufacturing site reports "we have received the complaint sample and confirmed for breakage.It seems lightguide has broken at bottom during snapping on handle." the manufacturer also reports it is confirmed that the device left the manufacturing site fully functional.The device history record of the lot number of the sample received (1906341) was reviewed and no issues that could have contributed to the reported failure were noted.The device was manufactured according to release specification.Based on the investigation performed, the complaint is confirmed.It seems that for some reason the device sustained unexplained physical damage.Because of the increasing trend in greenlite breakage complaints, a capa has been opened to address this issue.

Event Description

Customer complaint reported as: while using a laryngoscope blade during a life-saving emergency, the plastic base part of the laryngoscope blade broke in the handle.Clinical consequences: successful intubation with this broken blade but risk for the patient.No loss part in the patient.

• Brand Name: RUSCH GREENLITE DISP MTL MAC 4
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 10018667
• MDR Text Key: 189771705
• Report Number: 8030121-2020-00080
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 04/15/2020

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: IPN048387
• Device Catalogue Number: 004551004
• Device Lot Number: 1906341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2020
• Initial Date Manufacturer Received: 04/15/2020
• Initial Date FDA Received: 05/01/2020
• Supplement Dates Manufacturer Received: 05/25/2020
• Supplement Dates FDA Received: 05/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.