MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES 32CM GRASPER REPOS CART, 10/BX; NWV

Model Number C4119

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2014

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering confirmed that one of the latis pads was detached from the jaw.There was evidence that the inserts had come into contact with another sharp object.The root cause remains unknown, however; based on the evaluation of the returned product, this incident most likely resulted from contact with a sharp object.All graspers undergo 100% visual and functional inspection during the manufacturing and assembly process applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary to ensure the performance, safety, and efficacy of the 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 to 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 - "threads on gripping pad became detached (viewed on scope)." patient status - "ok.".

• Brand Name: 32CM GRASPER REPOS CART, 10/BX
• Type of Device: NWV
• 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: 6294219
• MDR Text Key: 66280945
• Report Number: 2027111-2017-00762
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915116859
• UDI-Public: (01)00607915116859(17)170126(30)01(10)1214523
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2017
• Device Model Number: C4119
• Device Catalogue Number: 100863901
• Device Lot Number: 1214523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/10/2014
• Initial Date FDA Received: 02/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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
• Patient Outcome(s): Other