MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CD003, 5MM RETRIEVAL SYSTEM, 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CD003

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2020

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: lap.Cholecystectomy.Detailed description of event: translation ame: to be able to retrieve the gallbladder, the incision was enlarged.During the retrieval the bag, as the user emphasizes, tore while pulling gently, in a place where experience has shown it to be very resistant to tearing.The bag has unfortunately been disposed of, but the customer will provide photos.The lot number also has to be provided still.Additional information received from applied medical representative via email on 07sep2020: the bag tore while removing the bag with the specimen inside.There was no contact with any instrument.The bag tore at the distal tip.The customer will provide a picture.The surgeon used his hand to pull on the cord loop.The surgeon used a new bag to remove the gallbladder.The lot is 1383620.Patient status: no patient status.Type of intervention: used a new bag to remove specimen.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant's experience of a torn tissue bag could not be confirmed.In the absence of the event unit, it is difficult to determine if the fragmented tissue bag was caused by a device non-conformance.However, based on the description of the event, it is likely that the bag broke from the stress exerted on the bag while the specimen was being removed from the extraction site.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Name of procedure: lap.Cholecystectomy.Detailed description of event: to be able to retrieve the gallbladder, the incision was enlarged.During the retrieval the bag, as the user emphasizes, tore while pulling gently, in a place where experience has shown it to be very resistant to tearing.The bag has unfortunately been disposed of, but the customer will provide photos.The lot number also has to be provided still.Additional information received from applied medical representative via email on 07sep2020: the bag tore while removing the bag with the specimen inside.There was no contact with any instrument.The bag tore at the distal tip.The customer will provide a picture.The surgeon used his hand to pull on the cord loop.The surgeon used a new bag to remove the gallbladder.The lot is 1383620.Patient status: no patient status.Type of intervention: used a new bag to remove specimen.

• Brand Name: CD003, 5MM 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: 10505090
• MDR Text Key: 206162768
• Report Number: 2027111-2020-00552
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123406
• UDI-Public: (01)00607915123406(17)230312(30)01(10)1383620
• Combination Product (y/n): N
• PMA/PMN Number: K100959
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2023
• Device Model Number: CD003
• Device Catalogue Number: 101072401
• Device Lot Number: 1383620
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1