MAUDE Adverse Event Report: APPLIED MEDICAL; GCJ

Model Number TBD

Device Problem Gas/Air Leak (2946)

Patient Problems Pulmonary Emphysema (1832); Hemorrhage/Bleeding (1888); Tissue Damage (2104); Respiratory Acidosis (2482)

Event Date 10/06/2015

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Procedure performed unknown."report from hospital reads as follows.'repeated problem with applied medical ports slipping out.This required multiple re-insertions (probably approx 12 times) so multiple tracts created.Gas leaking from port resulted in gross surgical emphysema.Patient became profound acidotic.The multiple re-insertions of the port also caused unnecessary soft tissue trauma and bleeding.' i was not in the operation to observe actual events.Product regularly ordered by this account are: (b)(4).

Manufacturer Narrative

Additional information was requested and not provided.Complete udi number unable to be provide as no model number or lot number could not be confirmed.Sales rep confirmed that there is no way of finding out exactly what specific product/lot was used.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.During the manufacturing process, all trocars are thoroughly inspected for functionality and performance prior to packaging.Applied medical has reviewed the details surrounding the incident and related products.At this time, applied medical is unable to determine the cause of the injury or confirm that a product malfunction occurred.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.

• Type of Device: GCJ
• 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: 5216036
• MDR Text Key: 31121973
• Report Number: 2027111-2015-00783
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 10/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: TBD
• Device Lot Number: TBD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/04/2016
• 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