MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER SITUATE; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number	L1818-04P01C-R
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a procedure, the device was linting.There was no patient injury.

• Brand Name: SITUATE
• Common Device Name: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 8794353
• Report Number: 1717344-2019-00906
• Device Sequence Number: 13947400
• Product Code: GDY
• UDI-Device Identifier: 10884521700970
• UDI-Public: 10884521700970
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/16/2019

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 Model Number: L1818-04P01C-R
• Device Catalogue Number: L1818-04P01C-R
• Device Lot Number: 170925A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1