MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH EQUIPLITE SU MTL BLADE MAC 4; LARYNGOSCOPE, RIGID

Catalog Number 004651004

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/17/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

The complaint is reported as: the blade broke apart during use on the patient.No pieces fell into the patient's mouth.The condition of the patient is reported as "fine".

Manufacturer Narrative

Qn#(b)(4).The sample was received and returned to the manufacturing site for evaluation.The manufacturing site reports a visual exam was performed and it was observed that the blade welding joints were broken although the metal was diffused properly at the welded joints.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.The blade was broken into two parts from the welded joints.This is a manufacturing related complaint.A capa has been opened to address this issue.

Event Description

The complaint is reported as: the blade broke apart during use on the patient.No pieces fell into the patient's mouth.The condition of the patient is reported as "fine".

• Brand Name: RUSCH EQUIPLITE SU MTL BLADE MAC 4
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 10652330
• MDR Text Key: 210517122
• Report Number: 8030121-2020-00150
• 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: 09/17/2020

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 Catalogue Number: 004651004
• Device Lot Number: 1904741
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/08/2020
• Supplement Dates Manufacturer Received: 10/29/2020
• Supplement Dates FDA Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LARYNGOSCOPE HANDLE.; LARYNGOSCOPE HANDLE.; LARYNGOSCOPE HANDLE