MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFS22, 12X100 KII SLEEVE ADVFIX 12/BX; GCJ

Model Number	10
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/25/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event product was returned to applied medical for evaluation.Upon inspection, engineering noted fragmentation of an internal rubber component of the seal.No rubber fragments were returned with the device, however, it was reported that no fragmentation was left in the patient.The likely root cause of the damage to the seal is an instrument.Applied medical's instructions for use states that "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing." applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.This report is being filed as a result of a re-review of applied medical complaints received between june 1, 2014 and may 31, 2016.This retrospective review was associated with a quality management system (qms) compliance action plan developed and presented to fda to address an april 10, 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
Procedure performed unknown:"this is a complaint from the market from the market.(b)(4).The defect unit and a fragment will be returned to amr.Please refer to the complaint sheet for investigation.The physician noticed a black fragment inside the body cavity.The septum was found to be broken.No damage was observed on the forceps and other surgical instruments.The defect unit and a black fragment were returned to (b)(4) and visually inspected: the septum was found to be damaged with a missing part that matched the fragment measuring approx.4.2 mm x 3.9 mm.Both the defect unit and the fragment will be returned to amr for evaluation.(b)(4)." patient status: no patient injury.

• Brand Name: CFS22, 12X100 KII SLEEVE ADVFIX 12/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6370646
• Report Number: 2027111-2017-01154
• Device Sequence Number: 16408097
• Product Code: GCJ
• UDI-Device Identifier: 00607915117740
• UDI-Public: (01)00607915117740(17)170804(30)01(10)1228855
• Combination Product (Y/N): N
• PMA/510(K) Number: 10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2017

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: 08/04/2017
• Device Model Number: 10
• Device Catalogue Number: 10
• Device Lot Number: 1228855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2015
• Initial Report FDA Received Date: 03/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1