MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLITE DISP METAL MILLER 1 BLADE; LARYNGOSCOPE, RIGID

Catalog Number 004550001

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The complaint was received via medwatch."light source of blade broke off during direct laryngoscopy, visualized in oropharynx and retrieved without difficulty." additional information was received by the user facility indicating the part was retrieved from the oropharynx without difficulty.No additional intervention was required.The patient had no harm from the event.

Manufacturer Narrative

Qn#(b)(4).Medwatch received - mw5096092.The customer returned one rusch greenlite disposable miller 1 blade for evaluation.Visual inspection of the blade confirmed that the light pipe was broken.The device history record of lot 1812411 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The complaint of a broken light pipe has been confirmed by this complaint investigation.A device history record review did not reveal any manufacturing related issues.A capa has already been issued to further investigate this issue.It has been determined under this capa that the root cause is packaging related.

Event Description

The complaint was received via medwatch."light source of blade broke off during direct laryngoscopy, visualized in oropharynx and retrieved without difficulty.".Additional information was received by the user facility indicating the part was retrieved from the oropharynx without difficulty.No additional intervention was required.The patient had no harm from the event.

• Brand Name: RUSCH GREENLITE DISP METAL MILLER 1 BLADE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 10707784
• MDR Text Key: 214615498
• Report Number: 8030121-2020-00151
• 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: company representative,other
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 004550001
• Device Lot Number: 1812411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Date Manufacturer Received: 11/13/2020
• Patient Sequence Number: 1
• Treatment: LARYNGOSCOPE HANDLE.; LARYNGOSCOPE HANDLE.