MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH TRULITE DISP BLADE&HANDLE MILL00 W/BATT; LARYNGOSCOPE, RIGID

Catalog Number 004670010

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/05/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported the light pipe shroud was sharp and may have lacerated the tissue in a neonatal airway.It was reported the physician assistant had difficulty intubating a patient and some blood was suctioned from the airway.The patient was successfully intubated and no further harm was reported.

Event Description

Customer reported the light pipe shroud was sharp and may have lacerated the tissue in a neonatal airway.It was reported the physician asssistant had difficulty intubating a patient and some blood was suctioned from the airway.The patient was successfully intubated and no further harm was reported.

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 it was observed that an inspection for sharpness of the blade (metallic part) was performed but no sharpness on the blade was found.The manufacturer also reports that they inspected the exposed area of the light guide (pipe) on a profile projector and it was found that the radius is as per drawings and no specific sharpness was found.There was a similar issue reported in (b)(6) 2018.At that time all inventory of the light guide (pipe) was reworked to remove sharp edges under a non-conformance.The product supplied under this lot (2j0818) is reworked and free from sharp edges.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.The device was found to conform with design specification.

• Brand Name: RUSCH TRULITE DISP BLADE&HANDLE MILL00 W/BATT
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 9141145
• MDR Text Key: 189451363
• Report Number: 8030121-2019-00089
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

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: 004670010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Manufacturer Received: 09/09/2019
• Initial Date FDA Received: 10/01/2019
• Supplement Dates Manufacturer Received: 11/04/2019
• Supplement Dates FDA Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.