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

Model Number IPN915445

Device Problem Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/23/2022

Event Type  malfunction  

Event Description

Reported issue: customer purchased two rusch laryngoscope green spec handles, product 004411100 in 2021.The handles are no longer working.They have tried new batteries and have tried several different blades on each handle and cannot get them to work.

Manufacturer Narrative

Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related event.

Manufacturer Narrative

(b)(4).The customer returned one rusch greenspec handle: medium for evaluation.The handle was visually inspected for signs of abuse/misuse/damage.Small scratches were found within the head of the handle which are indicative of normal wear.No signs of damage were observed.The handle was returned without batteries.A dimensional inspection was not required due to the nature of the complaint.Two known good lab inventory batteries were placed inside the returned handle.A known good lab inventory blade was also used as part of the functional inspection.Per ifu l07064, "attach blade to handle.Click in place.To switch on, pull blade up.To switch off, move blade down".The blade was attached however there was no illumination that appeared.The complaint is confirmed.The blade was detached and the handle was disassembled for further inspection.The batteries were removed and the terminals of the metal handle which connect to the batteries had no damage.The bulb assembly was removed and again no visual evidence of damage was observed.The xenon bulb within the bulb assembly was removed and replaced with a known good lab inventory bulb.The sample was then reassembled and tested with the previously used batteries and blade and the light was now properly illuminating.Therefore, it was determined that the xenon bulb was dead and needed to be replaced.Per ifu l07064, "pre-use checks: no illumination may indicate that the bulb needs replacing" and "bulb replacement: unscrew bulb holder then unscrew xenon 2.5v bulb and discard.Screw new bulb in tightly.Screw bulb holder back into place.Screw top back onto the handle ensuring secure closure.Perform pre-use checks." therefore, unintentional use additional testing was not required as the root cause has been attributed to normal wear error - normal wear appears to have caused or contributed to this complaint issue.The device history record of lot: 200101 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The complaint has been confirmed.No corrective or preventative actions are required as unintentional user error caused or contributed to this complaint issue.The complaint is confirmed.Upon functional inspection, it was observed that the handle could not illuminate a known good lab inventory blade and batteries.Upon further inspection, the xenon bulb within the bulb assembly was removed and replaced with a known good lab inventory bulb.The sample was then reassembled and tested with the previously used batteries and blade and the light was now properly illuminating.Therefore, it was determined that the xenon bulb was dead and needed to be replaced.Therefore, unintentional user error - normal wear appears to have caused or contributed to this complaint issue.Teleflex will continue to monitor and trend on complaints of this nature.

Event Description

Reported issue: customer purchased two rusch laryngoscope green spec handles, product: 004411100 in 2021.The handles are no longer working.They have tried new batteries and have tried several different blades on each handle and cannot get them to work.

• 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: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 15982865
• MDR Text Key: 308477210
• Report Number: 8030121-2022-00031
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026704711250
• UDI-Public: 14026704711250
• 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: 11/25/2022

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: Health Professional
• Device Model Number: IPN915445
• Device Catalogue Number: 004411100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/25/2022
• Initial Date FDA Received: 12/14/2022
• Supplement Dates Manufacturer Received: 01/12/2023
• Supplement Dates FDA Received: 01/13/2023
• 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: A
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.