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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTHCARE CORP CARDINAL HEALTH NEUROLOGICAL TRAY

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CARDINAL HEALTHCARE CORP CARDINAL HEALTH NEUROLOGICAL TRAY Back to Search Results
Model Number SNECGSPAUD
Device Problems Break (1069); Material Separation (1562)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/25/2017
Event Type  malfunction  
Manufacturer Narrative
The following elements have blank data.
 
Event Description
Patient was in operating room for a l4-5 anterior lumbar inter-body fusion performed by dr. As the surgeon was using #10 schwann morton knife blade on a long handle to dissect tissue off the vertebrae column, the knife blade broke in two pieces from the knife handle. This resulted with one piece falling to the side of the vertebrae where the surgeon had to remove tissue and suck blood carefully in order to identify the blade end that broke and safely remove it from the operating field. The other part of the blade remained on the knife handle and was safely removed from the field as well. Procedure was completed with no further incidents, knife blades from that spine pack from vendor schwann morton were all removed form the operating field and back table and replaced with a different manufacturer's knife blades. Vendor notified immediately upon incident reported by or nurse in the operating room. Manufacturer response for surgical disposable pack, pack surgical spine latex free (per site reporter). Email and phone call to area representative who filed the complaint with the company. The company removed all knife blades from schwann morton from this facilities' surgical spine packs and replaced them with a different manufacturer's knife blades per facility request, the replacement blade was requested to be thicker and sturdier to prevent breaking. Company also, notified facility that they would file an incident report with fda for the knife blades.
 
Event Description
Patient was in operating room for a l4-5 anterior lumbar inter-body fusion performed by dr. As the surgeon was using #10 schwann morton knife blade on a long handle to dissect tissue off the vertebrae column, the knife blade broke in two pieces from the knife handle. This resulted with one piece falling to the side of the vertebrae where the surgeon had to remove tissue and suck blood carefully in order to identify the blade end that broke and safely remove it from the operating field. The other part of the blade remained on the knife handle and was safely removed from the field as well. Procedure was completed with no further incidents, knife blades from that spine pack from vendor schwann morton were all removed form the operating field and back table and replaced with a different manufacturer's knife blades. Vendor notified immediately upon incident reported by operating room nurse in the operating room. Manufacturer response for surgical disposable pack, pack surgical spine latex free (per site reporter): email and phone call to area representative who filed the complaint with the company. The company removed all knife blades from schwann morton from this facilities' surgical spine packs and replaced them with a different manufacturer's knife blades per facility request, the replacement blade was requested to be thicker and sturdier to prevent breaking. Company also, notified facility that they would file an incident report with fda for the knife blades.
 
Event Description
Patient was in or for a l4-5 anterior lumbar inter-body fusion performed by dr. As the surgeon was using #10 schwann morton knife blade on a long handle to dissect tissue off the vertebrae column, the knife blade broke in two pieces from the knife handle. This resulted with one piece falling to the side of the vertebrae where the surgeon had to remove tissue and suck blood carefully in order to identify the blade end that broke and safely remove it from the operating field. The other part of the blade remained on the knife handle and was safely removed from the field as well. Procedure was completed with no further incidents, knife blades from that spine pack from vendor schwann morton were all removed form the operating field and back table and replaced with a different manufacturer's knife blades. Vendor notified immediately upon incident reported by or nurse in the operating room. Manufacturer response for surgical disposable pack, pack surgical spine latex free (per site reporter)
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email and phone call to area representative who filed the complaint with the company. The company removed all knife blades from schwann morton from this facilities' surgical spine packs and replaced them with a different manufacturer's knife blades per facility request, the replacement blade was requested to be thicker and sturdier to prevent breaking. Company also, notified facility that they would file an incident report with fda for the knife blades.
 
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Brand NameCARDINAL HEALTH
Type of DeviceNEUROLOGICAL TRAY
Manufacturer (Section D)
CARDINAL HEALTHCARE CORP
785 fort mill hwy.
fort mill SC 29707
MDR Report Key6878649
MDR Text Key260300806
Report Number6878649
Device Sequence Number1
Product Code OJG
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial,Followup,Followup
Report Date 08/21/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/01/2019
Device Model NumberSNECGSPAUD
Device Catalogue NumberSNECGSPAUD
Device Lot Number727298
Other Device ID Number#10 BLADE SCHWANN MORTON
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/21/2017
Device Age1 MO
Event Location Hospital
Date Report to Manufacturer08/21/2017
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/20/2017 Patient Sequence Number: 1
Treatment
NO OTHER DEVICE WAS BEING USED EXPECT A SELF RETAI; NO OTHER DEVICE WAS BEING USED EXPECT A SELF RETAI; NO OTHER DEVICE WAS BEING USED EXPECT A SELF RETAI; NO OTHER THERAPIES; NO OTHER THERAPIES; NO OTHER THERAPIES; NO OTHER DEVICE WAS BEING USED EXPECT A SELF RETAI; NO OTHER THERAPIES
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