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

Model Number CD001

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/30/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Name of procedure being performed: lap colon.Detailed description of event: while inserting in the abdomen and pushing down the thumb ring to open the bag, it turned out that there was no bag inside.What was very dangerous, however, was that the metal supports appeared out of the shaft.These are sharp, with a big risk of damaging the intestines.Additional information received from applied medical representative via email on 3-feb-2022: the date of event is (b)(6).No patient injury occurred.The patient has already been discharged from the hospital.The hospital thinks/hopes this was a 1-time event, they use inzii often and don't have any other problems.The procedure was a lap colon.No other devices were used at the same time as the inzii bag.The device will be returned.Patient status: already discharged from hospital.Type of intervention: hospitals thinks/ hopes this was a 1 time event, they use inzii often and don¿t have any other problems.

Event Description

Name of procedure being performed: lap colon.Detailed description of event: while inserting in the abdomen and pushing down the thumb ring to open the bag, it turned out that there was no bag inside.What was very dangerous, however, was that the metal supports appeared out of the shaft.These are sharp, with a big risk of damaging the intestines.Additional information received from applied medical representative via email on 3-feb-2022: the date of event is 30 december.No patient injury occurred.The patient has already been discharged from the hospital.The hospital thinks/hopes this was a 1-time event, they use inzii often and don't have any other problems.The procedure was a lap colon.No other devices were used at the same time as the inzii bag.The device will be returned.Patient status: already discharged from hospital.Type of intervention: hospitals thinks/ hopes this was a 1 time event, they use inzii often and don¿t have any other problems.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant¿s experience as the tissue bag was missing from the returned unit.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• 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
• Manufacturer Contact: aaron fulcher ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497135765
• MDR Report Key: 13588724
• MDR Text Key: 296407218
• Report Number: 2027111-2022-00403
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382(17)241026(30)01(10)1431651
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K060051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2022

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 Model Number: CD001
• Device Catalogue Number: 101473283
• Device Lot Number: 1431651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/28/2022
• Initial Date FDA Received: 02/23/2022
• Supplement Dates Manufacturer Received: 01/28/2022
• Supplement Dates FDA Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1