MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLITE DISP MTL MAC 3; LARYNGOSCOPE, RIGID

Model Number IPN048386

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported during the laryngoscopy, the light pipe separated from the blade.It was reported there was no consequence for the patient and no medical intervention was required.

Manufacturer Narrative

(b)(4).The sample was received and returned to the manufacturing site for evaluation.The manufacturing site reports a visual exam was performed and small broken pieces were observed in the packaging.It was also stated that the spot welding joint was intact.The manufacturer also reports that this product family is inspected 100% for functional testing (engagement, disengagement, light testing on handle) prior to shipment so it is confirmed that the device left the manufacturing site fully functional.The device history record was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.Based on the investigation performed, the complaint is confirmed.It seems that for some reason it sustained unexplained physical damage.The product cannot withstand the unexplained external impact.Because of the increasing trend in greenlite breakage complaints, a capa has been opened to address this issue.

Event Description

Customer reported during the laryngoscopy, the light pipe separated from the blade.It was reported there was no consequence for the patient and no medical intervention was required.

• Brand Name: RUSCH GREENLITE DISP MTL MAC 3
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 10154850
• MDR Text Key: 195252271
• Report Number: 8030121-2020-00087
• 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: 06/02/2020

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 Expiration Date: 04/15/2024
• Device Model Number: IPN048386
• Device Catalogue Number: 004551003
• Device Lot Number: 1905331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2020
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 06/15/2020
• Supplement Dates Manufacturer Received: 07/13/2020
• Supplement Dates FDA Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.