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

Model Number	SDK4190-FT
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was not returned for analysis.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 when the professor was trying to use the biopsy forceps to take lung tissue from the patient, plastic was taken out as well.When they tried to take a second time, plastic was taken out with lung tissue again.They changed to a new ewc and no plastic was found afterwards.The physician was able to complete the super dimension portion of the case.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: 8652595
• Report Number: 3004962788-2019-00044
• Device Sequence Number: 2275161
• Product Code: JAK
• UDI-Device Identifier: 10884521581388
• UDI-Public: 10884521581388
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K102604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• 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: 11/08/2021
• Device Model Number: SDK4190-FT
• Device Catalogue Number: SDK4190-FT
• Device Lot Number: 507901
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2019
• 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