MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C4120, 38CM GRASPER REPOS CART, 10/BX; NWV

Model Number C4120

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Bowel Perforation (2668); No Known Impact Or Consequence To Patient (2692)

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 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

Gastric bypass - "when grasping small bowel, noticed a hole in it." patient status - unknown.

Manufacturer Narrative

Further additional information was requested but not provided.The event unit was not returned for evaluation and no lot number was provided.In the absence of the subject device it is difficult to determine the exact root cause for the customer experience.Although the root cause of the event could not be determined, applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.This report is being filed as a result of a re-review of applied medical complaints received between june 1, 2014 and may 31, 2016.This retrospective review was associated with a quality management system (qms) compliance action plan developed and presented to fda to address an april 10, 2015 warning letter.Applied medical has revised its mdr reporting criteria to be more conservative and has improved complaint handling and mdr reporting processes.The reviews ensured that recent reportable events were appropriately identified and reported to the designated regulatory authority(ies).This report, which represents the initial and final reports combined, is being submitted based on the findings of that retrospective review.In accordance with 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.

Event Description

Additional information received via email from applied medical team member, may 1, 2016: "there was a hole in the small bowel.Unknown further intervention.".

• Brand Name: C4120, 38CM GRASPER REPOS CART, 10/BX
• Type of Device: NWV
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 5670652
• MDR Text Key: 45648191
• Report Number: 2027111-2016-00403
• Device Sequence Number: 1
• Product Code: NWV
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 03/07/2017

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: Health Professional
• Device Model Number: C4120
• Device Catalogue Number: 100864001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/25/2016
• Initial Date FDA Received: 05/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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