MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CD001, 10MM RETRIEVAL SYSTEM, 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CD001

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

The event unit is not anticipated to return.A follow-up report will be provided upon completion of the investigation.

Event Description

Name of procedure performed: laparoscopy ovarian cystectomy.[name], regular user of the item for a laparoscopy, specimen, teratoma / dermoid cyst.Pulled the bag trough incision and bag broke.No other or sharp instruments were used.A new bag was opened to remove the specimen and it worked.Patient status: patient is fine.Type of intervention: change of device.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.However, images of the event unit were provided.Engineering observed a hole in the tissue bag.Stretch marks were observed around the location of the hole.Based on the event description and the images provided, it is likely that the bag broke from the stress exerted on the bag while the specimen was being removed from the extraction site.It is possible that the port site was not properly sized for the specimen being removed.The instructions for use (ifu) states that "if the bag and its contents are too large to be extracted, carefully enlarge the port site for ease of bag removal.".

Event Description

Name of procedure performed: laparoscopy ovarian cystectomy.[name], regular user of the item for a laparoscopy, specimen, teratoma / dermoid cyst.Pulled the bag trough incision and bag broke.See attached images.No other or sharp instruments were used.A new bag was opened to remove the specimen and it worked.Patient status: patient is fine.Type of intervention: change of device.

• Brand Name: CD001, 10MM RETRIEVAL SYSTEM, 10/BX
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 10939170
• MDR Text Key: 219348792
• Report Number: 2027111-2020-00633
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382(17)230629(30)01(10)1388887
• Combination Product (y/n): N
• PMA/PMN Number: K060051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 12/29/2020

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: Health Professional
• Device Expiration Date: 06/29/2023
• Device Model Number: CD001
• Device Catalogue Number: 101473283
• Device Lot Number: 1388887
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/03/2020
• Supplement Dates Manufacturer Received: 11/25/2020
• Supplement Dates FDA Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1