MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFR03, 5X100 KII OPT ADVFIX 6/BX; GCJ

Model Number	18
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/03/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned for evaluation.Upon inspection, engineering determined that the unit functioned properly and met all specifications.The root cause could not be determined as engineering was unable to replicate the incident.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
Latg - "this is a complaint from the market.Administrative no.(b)(4).A black rubber fragment was found in the abdominal cavity after transection of esophagogastric junction.Procedure: latg.Instruments used in the procedure: ethicon stapler powered echlon, olympus video-scope endoeye flex ltf-190-10-3d, forceps, and gauze.The user facility returned all trocars used in the procedure as they could not identify the source of the fragment.Returned trocars: c0r47 (1), cfr47 (2), and cfr03 (2).This complaint sheet is for the cfr03s.Please refer to the complaint sheets admin#(b)(4) for the other trocars.Two cfr03s were returned to olympus and visually inspected: no damage was found with both units.The units will be returned to amr for further evaluation.Admin#(b)(4)." patient status- "no patient injury".

• Brand Name: CFR03, 5X100 KII OPT ADVFIX 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6370839
• Report Number: 2027111-2017-01164
• Device Sequence Number: 16456646
• Product Code: GCJ
• UDI-Device Identifier: 00607915119881
• UDI-Public: (01)00607915119881(17)171021(30)01(10)1233347
• Combination Product (Y/N): N
• PMA/510(K) Number: 18
• 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: Health Professional
• Device Expiration Date: 10/21/2017
• Device Model Number: 18
• Device Catalogue Number: 18
• Device Lot Number: 1233347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2015
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ETHICON STAPLER POWERED ECHLON, OLYMPUS VIDEO-SCOP