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

Model Number SDK4000-FT

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/14/2017

Event Type  malfunction  

Manufacturer Narrative

The product was not returned for analysis.A device history record review of the lot shows the lot was released meeting all quality specifications.However the reported behavior is consistent with a known issue in which an internal corrective action was initiated.

Event Description

The site reported that following removal of the biopsy forceps from the edge working channel (ewc), a string like fiber was removed with the biopsy forceps.The site reported nothing was left behind in the patient.There was no report of patient injury, death, or other serious adverse event.

Manufacturer Narrative

The device was returned on (b)(6) 2017 and evaluated.The results are consistent with the previously reported corrective action.

Manufacturer Narrative

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

• Brand Name: EDGE CATHETER SYSTEM
• 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: sharon murphy ; 161 cheshire lane; suite 100; minneapolis, MN 55441 ; 2034925267
• MDR Report Key: 6558563
• MDR Text Key: 74901284
• Report Number: 3004962788-2017-05047
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 10884521545557
• UDI-Public: 10884521545557
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SDK4000-FT
• Device Catalogue Number: SDK4000-FT
• Device Lot Number: 501600
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 93 YR