MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH DISPOLED SU FO HANDLE; LARYNGOSCOPE, RIGID

Model Number IPN045176

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 03/19/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that "battery compartment cover opened and battery fell out during use".No report of patient injury or harm.Patient condition unknown at time of report.

Event Description

It was reported that "battery compartment cover opened and battery fell out".No report of patient injury or harm.

Manufacturer Narrative

Qn# (b)(4).Additional information received indicates the event occurred when assembling the blade to the handle, prior to use on a patient.It was also reported that the patient condition is "ok".The actual sample was not returned; however, the customer provided two photos for evaluation.The manufacturing site reports "from the defect pictures, we could find that the spring is deformed and this indicated that the cap is rotated from disassembly or by mistake.Assembly part's spring is straight.The handle product is a disposable device, for one time use only.If user/someone rotate the battery cap by mistake or on purpose (for example: take the battery), then the device could not be assembled and used any more." without the actual device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: RUSCH DISPOLED SU FO HANDLE
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11616413
• MDR Text Key: 244692673
• Report Number: 8030121-2021-00017
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026704626127
• UDI-Public: 14026704626127
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPN045176
• Device Catalogue Number: 77700
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1