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

Model Number	SDK4190-FT
Medical Device Problem Codes	Retraction Problem (1536); Application Program Problem (2880); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/01/2022
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: EDGE
• Common Device Name: 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
• Report Number: 3004962788-2022-00017
• Device Sequence Number: 16559297
• Product Code: JAK
• UDI-Device Identifier: 10884521581388
• UDI-Public: 10884521581388
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K151376
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/16/2022

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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 03/17/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female