MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLITE DISP MTL MAC 1; LARYNGOSCOPE, RIGID

Catalog Number 004551001

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 03/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the physician tested the device and "a piece of plastic breaks off".No patient involvement reported.

Event Description

It was reported the physician tested the device and "a piece of plastic breaks off".No patient involvement reported.

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 reports that this product family is inspected 100% prior to shipment so it is confirmed that the device left the manufacturing site fully functional.The device history record of the lot number of the sample received 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 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.

• Brand Name: RUSCH GREENLITE DISP MTL MAC 1
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 10040459
• MDR Text Key: 197353711
• Report Number: 8030121-2020-00085
• 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: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 004551001
• Device Lot Number: 1809311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• Date Manufacturer Received: 06/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ULTRA-POWER LED HANDLE.; ULTRA-POWER LED HANDLE.