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

Catalog Number 004551004

Device Problem Break (1069)

Patient Problem Tooth Fracture (2428)

Event Date 03/10/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported the device broke in half during intubation.The blade hit tooth '9 and it became loose then fell out in pacu.It was reported that no medical intervention was required and the patient was "fine" at the time of this report.Medwatch form received and states: "a middle-aged female with history of elevated blood pressure and svt.Undergoing procedure ankle/foot arthrodesis/fusion and bone graft.Anesthesia assessment identified a loose #9 tooth and warned the patient of risk.During intubation, the crna advanced the laryngoscope and it snapped in half, causing the front tooth of the patient to loosen/dislocate from gum.In pacu, the tooth came out.".

Manufacturer Narrative

(b)(4).Medwatch uf/importer report#: (b)(4).The sample was received and returned to the manufacturing site for evaluation.The manufacturing site reports a visual exam was performed and it was observed that the blade welding joints were broken although the metal was diffused properly at the welded joints.The manufacturer also reports that this product family is inspected 100% for functional testing (engagement, disengagement, light testing on handle) prior to shipment so it is confirmed that the device left the manufacturing site fully functional.Strength of spot-welded joint cannot be tested for 100% which could lead to the possibility of shipping product with a weak spot-welding joint.The device history record was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.Based on the investigation performed, the complaint is confirmed.The blade was broken into two parts from the welded joints.The root cause is listed as manufacturing related.A capa has been opened to address this issue.

Event Description

Customer reported the device broke in half during intubation.The blade hit tooth '9 and it became loose then fell out in pacu.It was reported that no medical intervention was required and the patient was "fine" at the time of this report.Medwatch form received and states: "a middle-aged female with history of elevated blood pressure and svt.Undergoing procedure ankle/foot arthrodesis/fusion and bone graft.Anesthesia assessment identified a loose #9 tooth and warned the patient of risk.During intubation, the crna advanced the laryngoscope and it snapped in half, causing the front tooth of the patient to loosen/dislocate from gum.In pacu, the tooth came out.".

• Brand Name: RUSCH GREENLITE DISP MTL MAC 4
• Type of Device: LARYNGOSCOPE, RIGID
• Manufacturer (Section D): TELEFLEX MEDICAL; athlone
• MDR Report Key: 9873335
• MDR Text Key: 189442235
• Report Number: 8030121-2020-00043
• Device Sequence Number: 1
• Product Code: CCW
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 004551004
• Device Lot Number: 1907341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Initial Date Manufacturer Received: 03/11/2020
• Initial Date FDA Received: 03/24/2020
• Supplement Dates Manufacturer Received: 04/03/2020
• Supplement Dates FDA Received: 04/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 98