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

Model Number C4130

Device Problem Use of Device Problem (1670)

Patient Problems Injury (2348); Bowel Perforation (2668)

Event Date 04/17/2015

Event Type  Injury  

Event Description

Laparoscopic cholecystectomy- "dr (b)(6) was assisted by resident and after all access was placed and dissection begun, he was holding the bowel with the graspers and noticed full thickens puncture where he had the graspers.He looked at the other sections of the bowel that he had placed the graspers on and noticed 2 more full-thickness punctures.He opened the patient and had 3 bowel repairs.Dr (b)(6) has used the grasper in the past, including the day prior, with no issues.Surgeon states he was not holding the graspers differently and not sure what occasions happened, but would like the product to be inspected for flaws." type of intervention: case was converted to open.Patient status: doing well and fully informed of the situation the next day.

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.

Manufacturer Narrative

Investigation summary: one event unit was returned for evaluation.Upon inspection, engineering noted that the top pad of the unit was able to roll away from the jaw.The jaw of the detached pad did not have the required amount of adhesive.The customer's experience is attributed to a manufacturing error.Training has been conducted with manufacturing to develop a heightened awareness of this incident.We apologize for any inconvenience this may have caused and assure you that 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.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then a 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: 4779961
• MDR Text Key: 5882561
• Report Number: 2027111-2015-00288
• 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: Health Professional,User Facility,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/18/2015

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: 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: 05/27/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/21/2015
• Initial Date FDA Received: 05/19/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/14/2016
• 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
• Patient Outcome(s): Other; Required Intervention