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 08/28/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Type of procedure performed: ni."we have two failed products from the same procedure.The first broke and the second would not cinch, both bags broke.I have both items packaged in one return kit." "no adverse patient reaction." product available for return.Additional information received via email on 16oct2020 from [name]: no additional information has been provided from the account.No pictures are available of the device.Patient status: "no adverse patient reaction".Type of intervention: ni.

Event Description

Type of procedure performed: ni."we have two failed products from the same procedure.The first broke and the second would not cinch, both bags broke.I have both items packaged in one return kit." "no adverse patient reaction." product available for return.Additional information received via email on 16oct2020 from [name]: no additional information has been provided from the account.No pictures are available of the device.Patient status: "no adverse patient reaction." type of intervention: ni.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation without the tissue bag.As the tissue bag was not returned, applied medical was unable to confirm the complainant's experience of a broken tissue bag.In the absence of the tissue bag, it is difficult to determine if the tissue bag broke because of a manufacturing non-conformance.Applied medical has reviewed the details surrounding the event and is unable to determine the root cause of the event based on the evaluation of the partial unit and the description of the event.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• 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: 10729348
• MDR Text Key: 213920291
• Report Number: 2027111-2020-00595
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123406
• UDI-Public: (01)00607915123406(17)230602(30)01(10)1385005
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

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: 06/02/2023
• Device Model Number: CD003
• Device Catalogue Number: 101072401
• Device Lot Number: 1385005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 10/23/2020
• Supplement Dates Manufacturer Received: 10/13/2020
• Supplement Dates FDA Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1