MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC EDGE; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number SDK4900-FT

Device Problems Application Program Problem (2880); Connection Problem (2900)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/03/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).(canceled procedure) out of an abundance of caution, superdimension is filing this mdr due to the additional risk associated with multiple exposures to general anesthesia.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during procedure, the device's lg was detected as already used.It was the last kit so the physician was not able to complete the enb portion of the case.

• Brand Name: EDGE
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• MDR Report Key: 12495098
• MDR Text Key: 272141800
• Report Number: 3004962788-2021-00083
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 10884521545571
• UDI-Public: 10884521545571
• Combination Product (y/n): N
• PMA/PMN Number: K151376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SDK4900-FT
• Device Catalogue Number: SDK4900-FT
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2021
• 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
• Patient Outcome(s): Other