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 Patient Involvement (2645)

Event Date 02/28/2020

Event Type  malfunction  

Manufacturer Narrative

The event unit returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.

Event Description

Procedure performed: laparoscopic cystectomy.Detailed description of event: the scrub nurse removed the sterile retrieval system from the package.There was no bag with a string and a beat attached to the system.Additional information received via email from surgical sales specialist at [name] on 13mar20: the sister didn't deploy the system beforehand she did however notice that there was no string attached on the system and told the dr the dr then asked her to start deploying it which she did.There was no bag inside the shaft.Patient status: na.Type of intervention: ni.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation without the tissue bag.Applied medical is unable to confirm that the product was distributed to the customer without the tissue bag.Applied medical has reviewed the details surrounding the event and the returned unit 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

Procedure performed: laparoscopic systectomy.Detailed description of event: the scrub nurse removed the sterile retrieval system from the package.There was no bag with a string and a beat attached to the system.Additional information received via email from surgical sales specialist at [name] on 13mar20: the sister didn't deploy the system beforehand.She did however notice that there was no string attached on the system and told the dr.The dr then asked her to start deploying it which she did.There was no bag inside the shaft.Patient status: na.Type of intervention: ni.

• 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: 9880990
• MDR Text Key: 185002352
• Report Number: 2027111-2020-00441
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915117382
• UDI-Public: (01)00607915117382(17)221111(30)01(10)1370080
• Combination Product (y/n): N
• PMA/PMN Number: K060051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 05/04/2020

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: 11/11/2022
• Device Model Number: CD001
• Device Catalogue Number: 101473283
• Device Lot Number: 1370080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 03/25/2020
• Supplement Dates Manufacturer Received: 03/04/2020
• Supplement Dates FDA Received: 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1