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

Model Number IPN048387

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

Qn#: (b)(4).

Event Description

Customer complaint reported as: "happened in the cardiac resuscitation anesthesia department.The fiber optic of the blade broke and fell.Clinical consequences: no consequence for the patient but a waste of time because the patient was going to be intubated." it was reported the issue was observed prior to insertion in the patient, during the test.

Event Description

Customer complaint reported as: "happened in the cardiac resuscitation anesthesia department.The fiber optic of the blade broke and fell.Clinical consequences: no consequence for the patient but a waste of time because the patient was going to be intubated.".It was reported the issue was observed prior to insertion in the patient, during the test.

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 also 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 was reviewed and no issue that could have contributed to the reported failure was 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 4
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 10531099
• MDR Text Key: 206843949
• Report Number: 8030121-2020-00145
• 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: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN048387
• Device Catalogue Number: 004551004
• Device Lot Number: 2003341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2020
• Date Manufacturer Received: 08/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1