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

Model Number SDK4190-FT

Device Problems Retraction Problem (1536); Application Program Problem (2880); Activation, Positioning or Separation Problem (2906)

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

Event Date 03/01/2022

Event Type  Injury  

Event Description

According to the reporter, during the procedure, the physician was having difficulty pushing and retracting the extended working channel (ewc).Eventually the catheter and locatable guide (lg) were removed from the patient/scope but realized the tip of the lg had come off of the product.It was later found in the working channel of the scope.The physician was not able to complete the case and was not completed by other means.The patient was under general anesthesia.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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
• Manufacturer (Section G): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 13791452
• MDR Text Key: 289220265
• Report Number: 3004962788-2022-00017
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 10884521581388
• UDI-Public: 10884521581388
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151376
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SDK4190-FT
• Device Catalogue Number: SDK4190-FT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2022
• 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
• Patient Sex: Female