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 Type  malfunction  

Manufacturer Narrative

The event unit is not anticipated to return.A follow-up report will be provided upon completion of the investigation.This report is a follow-up report to medwatch report # (b)(4).

Event Description

Name of procedure performed: diagnostic laparoscopy, right salpingo-oophorectomy, peritoneal biopsy complaint based on medwatch report # (b)(4).Medwatch received on 13oct2020 via mail.The event date is unknown.The event occurred in (b)(6) 2020."10mm laparoscopic retrieval bag was placed inside abdomen via trocar port and hole noticed in bag.A 5mm laparoscopic retrieval bag was opened onto sterile field and a hole also noticed in bag after placement inside of the abdomen via trocar port.Both bags are taken out of the abdomen.New 5mm bag was provided to the sterile field and the specimen was collected.The surgeon requested a medsun be submitted for both bags.Per operative report: the ovary was placed in a bag - rupture of bag x2 due to force-non-penatrating issue." the patient is female, (b)(6) years old, and weighs (b)(6) kg.The received report does not list any preexisting patient characteristics that may have contributed to the event.Device is not available for evaluation.Additional information received via email on 15oct2020 from [name]: the bags did not break during specimen removal.It is unknown if the port site was enlarged prior to specimen removal.It is unknown if the specimen leaked back into the patient.There are no pictures available of the devices.The action being performed when the bag broke is "as stated in the medwatch report, the ovary was placed in a bag- rupture of bag x2 due to force- non-penatrating issue." patient status: no adverse event indicated.Type of intervention: "new 5mm bag was provided to the sterile field and the specimen was collected.".

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 applied medical was unable to confirm the complainant's experience of a hole in the tissue bag.In the absence of the event unit, it is difficult to determine if the hole in the tissue bag was caused by a manufacturing non-conformance.Applied medical has reviewed the details surrounding the event and is unable to determine the root cause 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.

Event Description

Name of procedure performed: diagnostic laparoscopy, right salpingo-oophorectomy, peritoneal biopsy complaint based on medwatch report # 4900240000-2020-8108.Medwatch received on 13oct2020 via mail the event date is unknown.The event occurred in sep2020."10mm laparoscopic retrieval bag was placed inside abdomen via trocar port and hole noticed in bag.A 5mm laparoscopic retrieval bag was opened onto sterile field and a hole also noticed in bag after placement inside of the abdomen via trocar port.Both bags are taken out of the abdomen.New 5mm bag was provided to the sterile field and the specimen was collected.The surgeon requested a medsun be submitted for both bags.Per operative report: the ovary was placed in a bag - rupture of bag x2 due to force-non-penatrating issue." the patient is female, 25 years old, and weighs 102 kg.The received report does not list any preexisting patient characteristics that may have contributed to the event.Device is not available for evaluation.Additional information received via email on 15oct2020 from [name]: the bags did not break during specimen removal.It is unknown if the port site was enlarged prior to specimen removal.It is unknown if the specimen leaked back into the patient.There are no pictures available of the devices.The action being performed when the bag broke is "as stated in the medwatch report, the ovary was placed in a bag- rupture of bag x2 due to force- non-penatrating issue." patient status: no adverse event indicated.Type of intervention: "new 5mm bag was provided to the sterile field and the specimen was collected.".

• 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: 10727403
• MDR Text Key: 223452346
• Report Number: 2027111-2020-00593
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382(17)230420(30)01(10)1387324
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

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: 04/20/2023
• Device Model Number: CD001
• Device Catalogue Number: 100864401
• Device Lot Number: 1387324
• Was Device Available for Evaluation?: No
• 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: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 102