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

Model Number IPN915460

Device Problem Material Separation (1562)

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

Event Date 09/23/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: "happened in the recovery room of the hospital.The laryngoscope blade broke during the opening of the packaging".No patient involvement reported.

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 april 2021.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.

Event Description

It was reported that: "happened in the recovery room of the hospital.The laryngoscope blade broke during the opening of the packaging".No patient involvement reported.

• Brand Name: RUSCH GREENLITE DISP MTL MAC 4
• Type of Device: LARYNGOSCOPE, RIGID
• MDR Report Key: 12638767
• MDR Text Key: 276667172
• Report Number: 8030121-2021-00033
• Device Sequence Number: 1
• Product Code: CCW
• UDI-Device Identifier: 14026704711403
• UDI-Public: 14026704711403
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/23/2021

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
• Device Operator: No Information
• Device Model Number: IPN915460
• Device Catalogue Number: 004551004
• Device Lot Number: 2104341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 10/15/2021
• Supplement Dates Manufacturer Received: 10/29/2021
• Supplement Dates FDA Received: 10/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1