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

Catalog Number 004411100

Device Problem Failure to Disconnect (2541)

Patient Problem Insufficient Information (4580)

Event Date 04/06/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "a resident cut his hand trying to push the blade closed".Resident condition unknown at time of report.Medical intervention unknown at time of report.Additional information requested however no further details of the incident was provided.

Event Description

It was reported that "a resident cut his hand trying to push the blade closed".Resident condition unknown at time of report.Medical intervention unknown at time of report.Additional information requested however no further details of the incident was provided.

Manufacturer Narrative

(b)(4).The customer returned one 004411100 rusch greenspec handle: medium for investigation.The handle was returned with an emerald rusch mac 3 blade attached to it.Visual examination did not reveal any obvious defects or anomalies as the device appears typical.All edges of the returned blade and handle were examined with no sharp edges or burrs observed that would be able to cut the hand of an end user as reported.Functional inspection was performed per laryngoscope ifu by pushing downward on the blade to release it from the handle.The blade was able to be removed from the handle with ease.The blade and handle were reattached and disassembled multiple times with no issues observed.There were several small scratch marks noted on the internal locking mechanism of the handle.These marks reveal that the device has been used multiple times by the end user and they are indicative of normal wear.There were no anomalies revealed during functional testing that would be able to cut the hand of an end user in any way.The device history record of lot 201101 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The ifu for this product states, "attach blade to compatible handle.Click into place.To switch on, pull blade up.To switch off , fold blade down.Return to off position after use." the complaint cannot be confirmed.No problem was found with the returned device.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: RUSCH GREENSPEC HANDLE: MEDIUM
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• Manufacturer (Section G): TRUPHATEK INTERNATIONAL LTD.; 14 benny gaon street; p.o. 8051; netanya 42504 43; IS 4250443
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 14255066
• MDR Text Key: 290444878
• Report Number: 8030121-2022-00018
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 004411100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/07/2022
• Initial Date FDA Received: 04/29/2022
• Supplement Dates Manufacturer Received: 05/25/2022
• Supplement Dates FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED
• Patient Outcome(s): Hospitalization