MAUDE Adverse Event Report: APPLIED MEDICAL C4130, 5MMX35CM EPIX LAPA GRASPER, 10/BX; NWV

Model Number C4130

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2015

Event Type  malfunction  

Manufacturer Narrative

This report is to follow up with maude report # (b)(4).The incident device anticipated to return.A follow-up report will be provided upon completion of investigation.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.

Event Description

Laparoscopic sleeve gastrectomy- "a piece of insulation from the tip of the applied medical epix laparoscopic grasper came off while using it intraoperatively.The broken piece of insulation was retrieved from patient's abdomen and the instrument sequestered.New epix laparoscopic grasper opened and utilized for the remainder of the procedure without incident.Diagnosis or reason for use.Robotic laparoscopic sleeve gastrectomy." patient status- "stable upon leaving o.R.".

Manufacturer Narrative

This report is a follow-up with maude report# mw5041364.Investigation summary: the event unit was returned for evaluation; one of the latis pads was missing from one of the jaws.This grasper pad was not returned with the event unit.Upon visual inspection, the remaining adhesive on the jaw retained the pattern of the pad, indicating even application of the adhesive and proper attachment of the pad.The root cause of the event was likely excessive force applied during surgical use.Engineering noted that grasper pads may detach when excessive force is applied.Applied medical actively monitors its vigilance system for trends and will take appropriate actions in order to continue providing our customers the highest quality products.In accordance with 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then the supplemental report will be submitted to the fda.

• Brand Name: C4130, 5MMX35CM EPIX LAPA GRASPER, 10/BX
• Type of Device: NWV
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer (Section G): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 4988402
• MDR Text Key: 22437553
• Report Number: 2027111-2015-00539
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/07/2015

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: Other
• Device Expiration Date: 11/16/2017
• Device Model Number: C4130
• Device Catalogue Number: 100915401
• Device Lot Number: 1234428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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