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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH GREENLITE DISP MTL MAC 3; LARYNGOSCOPE, RIGID
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TELEFLEX MEDICAL RUSCH GREENLITE DISP MTL MAC 3; LARYNGOSCOPE, RIGID Back to Search Results
Catalog Number 004551003
Device Problem Break (1069)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 09/19/2019
Event Type  Injury  
Manufacturer Narrative
Qn# (b)(4).Medwatch uf/importer report# 1601530000-2019-0001.
 
Event Description
During pre-op intubation by a student registered nurse anesthetist, the laryngoscope blade broke.The base of the blade remained attached to the handle and light remained on.When the blade broke it snapped the clear plastic fiber optic light source which flew into the air.The crna removed the blade which remained in the patient's mouth, checked for debris, and mask ventilated the patient while a glidescope was obtained for intubation.In checking the broken piece it appeared a small clear plastic piece was missing.Linens and surrounding area were thoroughly checked.The surgery went on as planned.Post operatively, a chest x-ray was done, but the fiber optic piece was determined not to be radiopague.A ct was done, resulting in a radiopague density measuring 8mm in the posterior basal right lower lobe.This was determined to be suspicious for a radiopague foreign body.A bronchoscopy was done for potential foreign body retrieval.No foreign body was retrieved.The physician suspected the finding on the ct was not indicative of a foreign body given the size and location.It was also reported the patient had some atelectasis.The patient is reported to be doing fine and is planned for a follow-up ct in 6 weeks.
 
Manufacturer Narrative
(b)(4).Medwatch uf/importer report# 1601530000-2019-0001 the sample was not returned; however, the customer provided a photo for evaluation.The manufacturer reports the photo was reviewed and it was observed that the blade welding joint was broken although metal was diffused.The manufacturer also reports that the product is inspected prior to release thus it is confirmed that it left the manufacturing facility fully functional.Strength of spot-welded joint cannot be tested for 100% which could lead to possibility of shipping product with weak spot welding joint.The dhr data (assembly testing, spot welding testing) was reviewed and no spot-welding breakage issue reported during inspection.Based on the investigation performed, the reported complaint was confirmed.It was observed that the blade was broken from the welded joints.The root cause was deemed as manufacturing related.A non-conformance was opened to address this issue.
 
Event Description
During pre-op intubation by a student registered nurse anesthetist, the laryngoscope blade broke.The base of the blade remained attached to the handle and light remained on.When the blade broke it snapped the clear plastic fiber optic light source which flew into the air.The crna removed the blade which remained in the patient's mouth, checked for debris, and mask ventilated the patient while a glidescope was obtained for intubation.In checking the broken piece it appeared a small clear plastic piece was missing.Linens and surrounding area were thoroughly checked.The surgery went on as planned.Post operatively, a chest x-ray was done, but the fiber optic piece was determined not to be radiopague.A ct was done, resulting in a radiopague density measuring 8mm in the posterior basal right lower lobe.This was determined to be suspicious for a radiopague foreign body.A bronchoscopy was done for potential foreign body retrieval.No foreign body was retrieved.The physician suspected the finding on the ct was not indicative of a foreign body given the size and location.It was also reported the patient had some atelectasis.The patient is reported to be doing fine and is planned for a follow-up ct in 6 weeks.
 
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Brand Name
RUSCH GREENLITE DISP MTL MAC 3
Type of Device
LARYNGOSCOPE, RIGID
Manufacturer (Section D)
TELEFLEX MEDICAL
athlone
MDR Report Key9180264
MDR Text Key168577067
Report Number8030121-2019-00099
Device Sequence Number1
Product Code CCW
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Type of Report Initial,Followup
Report Date 09/20/2019
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 No Information
Device Catalogue Number004551003
Device Lot Number1902331
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 09/20/2019
Initial Date FDA Received10/11/2019
Supplement Dates Manufacturer Received11/01/2019
Supplement Dates FDA Received11/04/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
RUSCH DISPOLED LARYNGOSCOPE HANDLE; RUSCH DISPOLED LARYNGOSCOPE HANDLE
Patient Outcome(s) Required Intervention;
Patient Age51 YR
Patient Weight91
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