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

Model Number C4130

Device Problem Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/26/2015

Event Type  malfunction  

Manufacturer Narrative

No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A final report will be sent once the results have been analyzed.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.This report is to follow up with medwatch report # (b)(4) and maude report# (b)(4).

Event Description

Subtotal colectomy - "during subtotal colectomy surgeon using instrument from applied medical "epix laparoscopic grasper" ref (b)(4) lot 1245061 green padding at grasping part of instrument fell off and inside the abdominal cavity.Surgeon saw something small and green on the screen, pulled out of patient and found to be padding on grasper.Grasper and pad were removed from the field and sent to manager." patient status - "unknown.".

Manufacturer Narrative

Full udi# provided.(b)(4).Investigation summary: the incident product was not returned for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the incident.A review of the manufacturing records indicates this lot passed all manufacturing and quality inspections. all graspers undergo a 100% visual and functional inspection during the manufacturing and assembly process.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: 5086388
• MDR Text Key: 26111194
• Report Number: 2027111-2015-00664
• 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: 09/17/2015

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: 04/16/2018
• Device Model Number: C4130
• Device Catalogue Number: 100915401
• Device Lot Number: 1245061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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