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 08/24/2015

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 sigmoid - "damaged insulation shaft.The concern was not electrical in nature, more that shaft material would end up in the patient's abdomen." patient status- ok.

Manufacturer Narrative

Investigation summary: one epix laparoscopic grasper was returned for evaluation.Upon visual inspection, engineering confirmed the product's insulation damage.Engineering was able to replicate the insulation damage, on a sample from production, with a similar ultrasonic cutting device.A review of the manufacturing history of this unit was unavailable as there was not lot number provided.The root cause of the incident is likely due to heat from the concomitant ultrasonic device.The instructions for use (ifu) indicate that, "when combining laparoscopic instruments from different manufacturers, confirm compatibility before the procedure." ultrasonic energy devices can reach very high temperatures and damage other instrumentation.Although the exact root cause of the customer's experience could not be determined, applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.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: 5076190
• MDR Text Key: 25736456
• Report Number: 2027111-2015-00638
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 09/14/2015

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 Model Number: C4130
• Device Catalogue Number: 100915401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/24/2015
• Initial Date FDA Received: 09/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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