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

Model Number C4130

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 01/01/2009

Event Type  malfunction  

Manufacturer Narrative

No product is being returned for evaluation and no lot # has been provided to manufacturer.A follow-up 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.

Event Description

Total abdominal colectomy - "instrument was used to occlude bowel while insufflating the rectum in order to test the integrity of the ileorectal anasmosis.After about 24hrs, the patient developed signs and symptoms of abdominal infection.Upon reexploration on enterotomy was identified at te site the instrument was used to occlude the bowel lumen." type of intervention- "re-exploration, repair of enterotomy." patient status- "alive and well.".

Manufacturer Narrative

The incident product was not returned for evaluation, and no lot number was provided.In the absence of the subject device, it is difficult to determine the root cause of the incident.A review of the manufacturing records for this lot could not be performed as no lot number was provided.  the root cause could not be determined as engineering was unable to conduct an evaluation.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary to ensure the performance and safety of our 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 Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 5487984
• MDR Text Key: 39934507
• Report Number: 2027111-2016-00180
• Device Sequence Number: 1
• Product Code: NWV
• UDI-Device Identifier: 00607915110147
• UDI-Public: 00607915110147
• 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: 02/08/2016

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?: No
• Device Operator: Other
• Device Model Number: C4130
• Device Catalogue Number: 101419801
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/08/2016
• Initial Date FDA Received: 03/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/21/2016
• 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
• Patient Outcome(s): Life Threatening; Other; Required Intervention