MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH MRI SET: HANDLE+ MIL 0,1 MAC 2,3,4; LARYNGOSCOPE, RIGID

Model Number	IPN915573
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "during the first use, we observed that 3 batteries out of 4 that are in the kit were not working.The blades have light only with 1 of the batteries.No light with the other 3 batteries".No patient involvement reported.
Additional Manufacturer Narrative
Qn#(b)(4).The sample was returned and sent to the manufacturing site for investigation.The device history record of lot 161102 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The manufacturing site reports "during investigation it is identify that battery cartridges has found out of warranty period & had exceeded the self-life of 18 months at the time of complaint reported.".
Event or Problem Description
It was reported that: "during the first use, we observed that 3 batteries out of 4 that are in the kit were not working.The blades have light only with 1 of the batteries.No light with the other 3 batteries".No patient involvement reported.

• Brand Name: RUSCH MRI SET: HANDLE+ MIL 0,1 MAC 2,3,4
• Common Device Name: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 11859058
• Report Number: 8030121-2021-00020
• Device Sequence Number: 4662327
• Product Code: CCW
• UDI-Device Identifier: 14026704712530
• UDI-Public: 14026704712530
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K062523
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2021

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 Expiration Date: 01/06/2022
• Device Model Number: IPN915573
• Device Catalogue Number: 5442M
• Device Lot Number: 161201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2021
• Initial Date Received by Manufacturer: 05/05/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1