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 09/27/2020

Event Type  malfunction  

Manufacturer Narrative

The event unit is expected to return for evaluation.A follow-up report will be provided upon completion of the investigation.

Event Description

Name of procedure being performed: cholecystectomy.Translation (b)(4): bag has torn.Probably just over the seal line of the thickening.Particles have come off, are being returned.Question is now whether all fragments have been found? the specimen was in the bag.Did not fall out.Patient has crohn's disease.Should an infection occur, it will be difficult to determine whether it's because of remaining fragments or because of the co-morbidity.Patient status: patient seems fine so far.Type of intervention: ni.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation and images of the event unit were also provided.Engineering observed a hole in the distal portion of the tissue bag and stretch marks were observed around the break.The images confirmed that the bag had fragmented; however, the fragments were not returned for evaluation.Based on the condition of the returned unit, 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 being performed: cholecystectomy bag has torn.Probably just over the seal line of the thickening.Particles have come off, are being returned.Question is now whether all fragments have been found? the specimen was in the bag.Did not fall out.Patient has crohn's disease.Should an infection occur, it will be difficult to determine whether it's because of remaining fragments or because of the co-morbidity.Patient status: patient seems fine so far.

• 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: 10596611
• MDR Text Key: 209805332
• Report Number: 2027111-2020-00569
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1