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

Model Number IPN048387

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 02/27/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported "when opening the packaging, we observed that the lighting part of the blade is detached from the blade.".A new device was used for patient care.

Manufacturer Narrative

(b)(4).The sample was returned by the customer however the manufacturer has reported "it is confirmed that a sample stuck in transit and held at delhi warehouse due to some custom clearance documentation issues and there is possibility that again it will get delay to arrive at chandigarh site.If in the event that the sample is delivered to the site for investigation, the complaint will be reopened, and a sample investigation will be conducted." a device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.

Event Description

Customer reported "when opening the packaging, we observed that the lighting part of the blade is detached from the blade.".A new device was used for patient care.

• Brand Name: RUSCH GREENLITE DISP MTL MAC 4
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 10208452
• MDR Text Key: 197353413
• Report Number: 8030121-2020-00088
• 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: 06/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2020
• 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: 1912341
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1