MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES KII 5X100 FIOS Z-THR; GCJ

Model Number 14

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2014

Event Type  malfunction  

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.The root cause of the event is applying excessive force during insertion of the device.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 Description

Laparoscopic gastric sleeve- "during trocar insertion of far left lateral port the surgeon readjusted the angle of insertion.With trocar still partially inserted the surgeon lifted up on the trocar while pushing down on the seal housing.Carrying the weight of patient's pannus the trocar crimped in half.The patient has a bmi of (b)(6) and has had multiple previous surgeries including open appy, open chole, and multiple c/s." patient status: normal.

• Brand Name: KII 5X100 FIOS Z-THR
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 6372836
• MDR Text Key: 68830678
• Report Number: 2027111-2017-01059
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915117733
• UDI-Public: (01)00607915117733(17)170403(30)01(10)1223380
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 14
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2017
• Device Model Number: 14
• Device Catalogue Number: 14
• Device Lot Number: 1223380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ANOTHER CTF03 WAS OPENED AND USED