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 08/11/2015

Event Type  malfunction  

Manufacturer Narrative

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

Lap chole - "when grasping the gallbladder, dr (b)(6) noticed one of the pads had detached.A second grasper was opened to complete the case.The surgeon was able to retrieve the pad." patient status - "procedure completed without further incident.".

Manufacturer Narrative

Investigation summary: the event unit was returned for evaluation along with the detached pad.Upon visual inspection, engineering noted the remaining material on the jaw was even across the surface, indicating adhesive was applied uniformly and in sufficient amounts during manufacturing.Additionally, it was also noted that the shaft was broken.The exact cause of the pad detachment is unknown; however, it may have been due to excessive force during surgical use.The pad remnant and broken shaft indicate that the unit was likely subjected to forces greater than it could withstand.Applied medical actively monitors its vigilance system for trends and will take appropriate actions, where necessary, 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: 5079526
• MDR Text Key: 25878788
• Report Number: 2027111-2015-00647
• 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: Initial,Followup
• Report Date: 09/15/2015

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
• Device Operator: Other
• Device Expiration Date: 10/19/2017
• Device Model Number: C4130
• Device Catalogue Number: 100915401
• Device Lot Number: 1233161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/26/2015
• Initial Date FDA Received: 09/15/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2014
• 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