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

Model Number	SDK4000-FT
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned.However, the reported behavior is consistent with a known issue in which an internal corrective action was initiated.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a procedure, upon removal of the specimen from the catheter, there appeared to be a thin line of plastic that separated or sliced from the 180 catheter and came out along with the specimen (approx.53cm).There was no patient injury.

• 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
• MDR Report Key: 8649705
• Report Number: 3004962788-2019-00042
• Device Sequence Number: 16209030
• Product Code: JAK
• UDI-Device Identifier: 10884521545557
• UDI-Public: 10884521545557
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K102604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/12/2021
• Device Model Number: SDK4000-FT
• Device Catalogue Number: SDK4000-FT
• Device Lot Number: 508312
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1