MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFR73, 12X100 KII OPT ADVFIX 6/BX; GCJ

Model Number	21
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event product was returned to applied medical for evaluation.Upon inspection, engineering noted damage to internal rubber components of the seal.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
Gs surgery for liver /cholecyst/pancreas - "this is a complaint from the market.Administrative no.(b)(4).The event unit and two sheets of tyvek will be returned to amr.No credit or replacement is needed as model # and lot # cannot be identified.Please refer to the investigation sheet for complaint." complaint sheet - "the septum was damaged when an echo probe was inserted/withdrawn into/from the seal and the fragment fell inside the body.Combined instruments: echo probe, 10 mm rigid endoscope, powered echelon, harmonic ace+, ligasure blunt, ligasure maryland, grasper, dissector, scissors, and needle driver~ procedure: gs surgery for liver/cholecyst/pancreas.The event unit and two sheets of tyvek were returned to olympus.One of the tyvek sheets showed the model # of cfr73 with lot # of 1251017.The other sheet showed the model # of cfs22 and the lot # of 1247889.Olympus was unable to identify which model / lot #s are correct,thus would like amr to review the manufacturing records for the both lots, no credit or replacement is needed.Upon visual inspection,the ddb was found to have a cut.The septum was torn and one of the shields stuck out or the tear, the septum appeared to have no missing portion and no fragments were sent to olympus.The unit will be returned to amr for further evaluation.Admin#(b)(4)." patient status - no patient injury.

• Brand Name: CFR73, 12X100 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: 6370916
• Report Number: 2027111-2017-01437
• Device Sequence Number: 769055
• Product Code: GCJ
• UDI-Device Identifier: 00607915119898
• UDI-Public: (01)00607915119898(17)180715(30)01(10)1251017
• Combination Product (Y/N): N
• PMA/510(K) Number: 21
• 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: 07/15/2018
• Device Model Number: 21
• Device Catalogue Number: 21
• Device Lot Number: 1251017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2015
• 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: ECHO PROBE, 10 MM RIGID ENDOSCOPE, POWERED ECHELON