MAUDE Adverse Event Report: H.S. HOSPITAL SERVICE SPA TRAPSYSTEM SET; INSTRUMENT, BIOPSY

Model Number	TRAPSYSTEM SET
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Jamshidi needle broke during biopsy.Second device to break this month.

• Brand Name: TRAPSYSTEM SET
• Common Device Name: INSTRUMENT, BIOPSY
• Manufacturer (Section D): H.S. HOSPITAL SERVICE SPA; 4521-31 north dixie highway; boca raton FL 33431
• MDR Report Key: 7243615
• Report Number: 7243615
• Device Sequence Number: 933487
• Product Code: KNW
• UDI-Device Identifier: 08033003347881
• UDI-Public: (01)08033003347881
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/26/2018
• Report Date (Section F): 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Nurse
• Device Expiration Date: 04/29/2022
• Device Model Number: TRAPSYSTEM SET
• Device Catalogue Number: TRAPJ 1110
• Device Lot Number: 28929
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 01/26/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/06/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO
• Date Report Sent to FDA: 01/26/2018