MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R50, 12X130 KII BALLOON BLNT TIP 6/BX; GCJ

Model Number 14

Device Problem Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/20/2015

Event Type  malfunction  

Manufacturer Narrative

The event product was returned to applied medical for evaluation.Upon inspection, engineering noted no damage to the seal or its internal components.The device met current specifications.The root cause is likely the repeated insertion and removal of gauze.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

Procedure performed unknown: "this is a complaint from the market.(b)(4).Please refer to the complaint sheet for investigation.It was difficult to insert scope into the seal.Scope got stuck with septum when it was through the seal at the final phase of the procedure, using da vinci.User wiped and cleaned ddb and septum using gauze several times during the procedure.Grease in the ddb and septum may be cleaned off at the time.The actual defect unit was returned to olympus and visually inspected.No damage was found on the unit.Please analyze this complaint phenomenon and review the device history record.(b)(4)." patient status: no patient injury.

• Brand Name: C0R50, 12X130 KII BALLOON BLNT TIP 6/BX
• 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: 6370650
• MDR Text Key: 68772471
• Report Number: 2027111-2017-01179
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915116460
• UDI-Public: (01)00607915116460(17)160611(30)01(10)1225014
• Combination Product (y/n): N
• PMA/PMN Number: 14
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/11/2016
• Device Model Number: 14
• Device Catalogue Number: 14
• Device Lot Number: 1225014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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