MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENSPEC FO HANDLE SMALL; LARYNGOSCOPE HANDLE

Catalog Number 004411100

Device Problem Temperature Problem (3022)

Patient Problem Burn(s) (1757)

Event Date 05/28/2015

Event Type  malfunction  

Event Description

The customer reports that during a pre-check the handle was extremely hot to touch.The handle was reported to have burned the nurse.No treatment needed.The handle was replaced with a functioning handle.

Manufacturer Narrative

Qn#(b)(4).The device sample was not returned for evaluation at the time of this report.

Manufacturer Narrative

(b)(4).The sample was not returned for investigation; therefore, the complaint could not be confirmed.If the sample is returned, a follow-up report will be submitted with investigation results.

Event Description

The customer reports that during a pre-check the handle was extremely hot to touch.The handle was reported to have burned the nurse.No treatment needed.The handle was replaced with a functioning handle.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the light assembly which incorporates the electrical insulators was removed and it was confirmed that one of the primary electrical insulators on the battery contact end was missing from its retainer collar.No other signs of abuse or misuse detected.Based on the visual exam, the reported complaint was confirmed.The sales rep has reported that the user does not remove the "bulb chamber" from the handle prior to the sterrad (peroxide and plasma gas) sterilization process.The teleflex ifu states that the "bulb chamber" should be removed from the handle prior to this sterilization process.The sterrad sterilization process has been known to have detrimental chemical effects on certain plastics and rubbers.While the condition reported on these handles cannot be replicated in house, it should be noted that the continuous practice of not removing the bulb chamber, which incorporates the missing insulators during the sterrad sterilization process, could have a detrimental effect on the plastic insulators causing them to deteriorate and dislodge.From an investigation perspective, the missing insulator can easily cause an electrical short condition which in turn leads to the handle heating.

Event Description

The customer reports that during a pre-check the handle was extremely hot to touch.The handle was reported to have burned the nurse.No treatment needed.The handle was replaced with a functioning handle.

• Brand Name: RUSCH GREENSPEC FO HANDLE SMALL
• Type of Device: LARYNGOSCOPE HANDLE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 2917 weck drive; research triangle park NC 27709
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 4868812
• MDR Text Key: 18637364
• Report Number: 1044475-2015-00175
• 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,Followup
• Report Date: 06/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 004411100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/04/2015
• 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