MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH MRI HANDLE BATTERIES PACK OF 1; LARYNGOSCOPE, RIGID

Model Number IPN048614

Device Problem Battery Problem (2885)

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

Event Date 12/30/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "the battery stopped working [when] we took [the] scope out to use on our patient".No patient involvement reported.

Manufacturer Narrative

Qn#(b)(4).The customer returned one 005853300 rusch mri handle batteries pack of 1 for investigation.Visual examination did not reveal any obvious defects or anomalies.Additionally, the customer stated that only one battery was received in the packaging and they were expecting two batteries.It should be noted that this product is a "pack of 1", so the correct quantity was packaged and received.Functional inspection was performed per mri laryngoscope ifu by inserting the battery into a known good lab inventory rusch mri laryngoscope handle and attaching a known good lab inventory blade onto the handle.The led lit up and stayed lit for 5 minutes.The light did not turn off or get dim.The complaint cannot be confirmed.The battery voltage was measured to be 3.18 dc volts which is consistent with the nominal voltage.The device history record of lot 21100101 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The instructions for use (ifu) provided with this device advises the user, "check battery pack is inserted correctly into the handle.Arrow should point into the handle cavity.Do not expose the battery to water or heat.".

Event Description

It was reported "the battery stopped working [when] we took [the] scope out to use on our patient".No patient involvement reported.

• Brand Name: RUSCH MRI HANDLE BATTERIES PACK OF 1
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 13334048
• MDR Text Key: 285255964
• Report Number: 8030121-2022-00001
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026704616272
• UDI-Public: 14026704616272
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: IPN048614
• Device Catalogue Number: 005853300
• Device Lot Number: 21100101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2022
• 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: Reuse
• Patient Sequence Number: 1