MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH DOPHIN STD WTR RESIST HD; LARYNGOSCOPE HANDLE

Catalog Number 145000

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 01/27/2014

Event Type  malfunction  

Event Description

The event is reported as: the dolphin handle was being prepared for the operating room tray when the clinician discovered the locking pin missing on the handle head.

Manufacturer Narrative

Upon visual inspection, the handle displays obvious signs of heavy wear where the blade ball bearings make contact with the handle head assembly.The lot/serial # which is stamped into the head of the handle reflects 9902, which indicates the handle was manufactured in the second month of 1999, or february 1999.This handle has been in use for approximately fourteen years.The complaint has been confirmed.The actual root cause of what happened to the locking pin cannot be established with the information that has been provided.However it should be noted that these handles have been in use for approximately fourteen years, and by the visual signs of use displayed on the actual handle, it should have been rotated out of service long ago.No corrective/preventative actions will be assigned.No conclusion code available for related issue.

• Brand Name: RUSCH DOPHIN STD WTR RESIST HD
• Type of Device: LARYNGOSCOPE HANDLE
• Manufacturer (Section D): TELEFLEX MEDICAL; nuevo laredo, tamaulipas ; MX
• Manufacturer Contact: margie burton, rn ; p.o. box 12600; durham, NC 27709 ; 9194334965
• MDR Report Key: 3824130
• MDR Text Key: 17932147
• Report Number: 3004365956-2014-00072
• 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: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 145000
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/05/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/1999
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1