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

Model Number	IPN045176
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem 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 or Problem Description
It was reported that "battery compartment cover opened and battery fell out".No report of patient injury or harm.
Additional 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
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11616413
• Report Number: 8030121-2021-00017
• Device Sequence Number: 2987746
• Product Code: CCW
• UDI-Device Identifier: 14026704626127
• UDI-Public: 14026704626127
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

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
• Operator of Device: No Information
• Device Model Number: IPN045176
• Device Catalogue Number: 77700
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1