MAUDE Adverse Event Report: APPLIED MEDICAL EUROPE BV CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX; GCJ

Model Number CD004

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2016

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

Lap right hemihepatectomy - "i used the large am bag last week for a lap right hemihepatectomy.Unfortunately, the bag ripped and therefore the specimen was left inside.' still trying to ascertain additional details.Including whether there was patient harm, whether the bag was kept for analysis, additional procedural details etc." additional info received via email from applied medical team member, december 8, 2016: liver resection with a very large specimen.Mr (b)(6) (consultant hpb surgeon).Nothing different, no additional instrument or contact noticed.Bag broke at the bottom/seal? it has been saved and will be decontaminate.Specimen was retrieved but surgeon was concerned that he'd been unable to contain cancerous tissue within the bag.Patient status - no injury/illness associated.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the event.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.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.

• Brand Name: CD004, 12/15MM RETRIEVAL SYSTEM, 5/BX
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL EUROPE BV; wiekenweg 21; amersfoort 3815 KL; NL 3815 KL
• Manufacturer Contact: loananh nguyen ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 6216637
• MDR Text Key: 63691088
• Report Number: 2027111-2016-00932
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K060051
• 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: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CD004
• Device Catalogue Number: 101388201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/06/2016
• 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