MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLED HANDLE: MEDIUM; LARYNGOSCOPE, RIGID

Catalog Number 133300

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "the blade is loose when it is snapped on the handle".No patient involvement reported.

Event Description

It was reported "the blade is loose when it is snapped on the handle".No patient involvement reported.

Manufacturer Narrative

Qn# (b)(4).The sample was returned and sent to the manufacturer for investigation.The manufacturer reports the sample was inspected and it was found that the blade is loose on the handle.Manufacturer also reports "during investigation it has been identified that groove of the handle was observed wear out and we have performed functional testing on handle and observed that blade was loose on handle and it is getting unlock under very less pressure.But as per ifu instructions for inspection and controls: it is recommended that always inspect the device for damage or increased wear and do not re-use damaged or worn devices".The device history record of lot 191001 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The returned device met design specification; however, the manufacturer reports the groove of the handle was worn out indicating the defect was related to the user.Per ifu instruction, it is recommended not to reuse damaged or worn devices.

• Brand Name: RUSCH GREENLED HANDLE: MEDIUM
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11139272
• MDR Text Key: 225822324
• Report Number: 8030121-2021-00003
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 133300
• Device Lot Number: 191001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2021
• Date Manufacturer Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BLADE; BLADE; BLADE