MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTB03, 5X100 KII SH BLD ZTHR 6/BX; GCJ

Model Number	17
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/22/2014
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event product was returned to applied medical for evaluation.Due to the shield not being returned for evaluation, engineering was unable to physically evaluate (the shield) and determine the root cause.This report is being filed as a result of a re-review of applied medical complaints received between (b)(6) 2014 and (b)(6) 2016.This retrospective review was associated with a quality management system (qms) compliance action plan developed and presented to fda to address an (b)(6) 2015 warning letter.Applied medical has revised its mdr reporting criteria to be more conservative and has improved complaint handling and mdr reporting processes.The reviews ensured that recent reportable events were appropriately identified and reported to the designated regulatory authority(ies).This report, which represents the initial and final reports combined, is being submitted based on the findings of that retrospective review.In accordance with 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.
Event or Problem Description
Lap appendicectomy - "aspirating ovarian cyst with lap needle.When removed needle from port part of the seal came out with the needle.When the instrument guard (clear plastic circular flange) was examined there were only 7 segments left, two had sheared off.Once came out with needle and had to search for the other segment in the abdomen.This was located and removed.An extra 5mm port was inserted to find segment." patient status - fine.

• Brand Name: CTB03, 5X100 KII SH BLD ZTHR 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6372908
• Report Number: 2027111-2017-01088
• Device Sequence Number: 19027529
• Product Code: GCJ
• UDI-Device Identifier: 00607915123512
• UDI-Public: (01)00607915123512(17)170327(30)01(10)1219479
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: 17
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/02/2017

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: Other
• Device Expiration Date: 03/27/2017
• Device Model Number: 17
• Device Catalogue Number: 17
• Device Lot Number: 1219479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2014
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2014
• Initial Report FDA Received Date: 03/02/2017
• 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: ASPIRATION LAP NEEDLE