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

Catalog Number 004411100

Device Problem Failure to Disconnect (2541)

Patient Problem No Patient Involvement (2645)

Event Date 08/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported "blades appear that they are too tight on the handle causing them to jam and not release from handle." during pre-testing.There was no patient involvement reported.

Event Description

Customer reported "blades appear that they are too tight on the handle causing them to jam and not release from handle." during pre-testing.There was no patient involvement reported.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and some metal displacement was noted in the blade ball bearing cutouts.This metal displacement appears to be the result of normal usage, day to day blade engagement and disengagement.In order to attempt replication of the reported defect, three (3) blades were attached to the reported defect handle.The blades used were: emerald mac 3.5, reusable (product code 004433500), rusch green lite miller 4, disposable (product code 004550004), and emerald mac 1, reusable (product code 004431100).All of these blades attached, engaged, disengaged, and detached multiple times without any problems.A review of the attached dhr/inspection record did not reflect any issues related to manufacturing activities.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned sample.

• Brand Name: RUSCH GREENSPEC FO HANDLE MEDIU
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 8981544
• MDR Text Key: 189453877
• Report Number: 8030121-2019-00075
• 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: 08/19/2019

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: 004411100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Initial Date Manufacturer Received: 08/19/2019
• Initial Date FDA Received: 09/10/2019
• Supplement Dates Manufacturer Received: 09/27/2019
• Supplement Dates FDA Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED; NONE REPORTED