MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES 5X100MM KII SLEEVE ADVANCED FIXATION 12/BX; GCJ

Model Number	8
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/14/2014
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.Engineering was unable to replicate and confirm the root cause of the event as the unit functions as designed.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((b)(6)).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 chole- "surgeon experienced abnormally high drag when using clip applier in advanced fixation trocar.Surgeon was using cfs02 at the epigastric port for cholangiogram placement.There was enough drag that surgeon could not articulate to secure catheter.He request ethicon ligamax 5 to complete the case.The trocar in use is also being returned.The model # is cfs02.The lot number is 1218613.One each." patient status: unaffected.

• Brand Name: 5X100MM KII SLEEVE ADVANCED FIXATION 12/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6372825
• Report Number: 2027111-2017-01087
• Device Sequence Number: 1081146
• Product Code: GCJ
• UDI-Device Identifier: 00607915117733
• UDI-Public: (01)00607915117733(17)170403(30)01(10)1218613
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: 8
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• 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: 04/03/2017
• Device Model Number: 8
• Device Catalogue Number: 8
• Device Lot Number: 1218613
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2014
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2014
• 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: ETHICON LIGAMAX 5