MAUDE Adverse Event Report: RUSCH GREENLITE DISP MTL MAC 4; LARYNGOSCOPE, RIGID

Model Number	IPN048387
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "when the blade was snapped on the laryngoscope handle, the plastic part broke".No patient involvement reported.
Additional Manufacturer Narrative
(b)(4).The actual device was returned and sent to the manufacturing site for evaluation.The manufacturing site reports: "the complaint sample was visually inspected by the chandigarh investigating team and the customer reported failure mode was verified and confirmed, i.E., the light pipe was broken as stated in the complaint.The device history record for lot code 2104341 was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification." manufacturer's conclusion: "the complaint of a light guide breakage in rusch greenlite mac 4 product inside the packaging was confirmed by complaint investigation.Small broken pieces are observed in packaging.The spot-welding joint in the sample was intact.Product was manufactured at the chandigarh site in dec 2019.The complaint sample reveals that the base of the light guide is broken inside the packaging.The product was manufactured and packed in india.We inspect this product family 300% prior to shipment from india so we can state that it left the manufacturing site fully functional.The root cause of this complaint is deemed packaging related." a capa was opened to address this issue.The device was manufactured prior to the correction action.
Event or Problem Description
It was reported that: "when the blade was snapped on the laryngoscope handle, the plastic part broke".No patient involvement reported.

• Brand Name: RUSCH GREENLITE DISP MTL MAC 4
• Common Device Name: LARYNGOSCOPE, RIGID
• MDR Report Key: 12668706
• Report Number: 8030121-2021-00034
• Device Sequence Number: 13755029
• Product Code: CCW
• UDI-Device Identifier: 14026704663139
• UDI-Public: 14026704663139
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021

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: 11/01/2024
• Device Model Number: IPN048387
• Device Catalogue Number: 004551004
• Device Lot Number: 1912341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Initial Date Received by Manufacturer: 09/30/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 10/20/2021
• Supplement Report FDA Received Date: 10/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1