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

Model Number CD001

Device Problems Retraction Problem (1536); Detachment of Device or Device Component (2907)

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

Event Date 02/25/2022

Event Type  malfunction  

Manufacturer Narrative

No product is being returned for evaluation and no lot number has been provided to applied medical.A follow-up report will be provided upon completion of the investigation.

Event Description

Name of procedure being performed: ralp (robot ass lap prostatectomy).Detailed description of event: complaint 1 of 2: complaint # (b)(4) (lot 1438852).Complaint 2 of 2: complaint # (b)(4) (lot unknown).This was the 2nd time they had issues with cd001: the bead got stuck in the white shaft of the device and when they pulled the cord the bead came loose.The 1st time it also happened but they found out later that the bead was missing.Both times outside the abdomen.No instruments saved and only the lot# of the 2nd time it occured.Patient status: patient is ok.Type of intervention: ni.

Event Description

Name of procedure being performed: ralp (robot ass lap prostatectomy).Detailed description of event: complaint 1 of 2: complaint # (b)(4) (lot 1438852) - mfr 2027111-2022-00527.Complaint 2 of 2: complaint # (b)(4) (lot unknown) - mfr 2027111-2022-00528.This was the 2nd time they had issues with cd001: the bead got stuck in the white shaft of the device and when they pulled the cord the bead came loose.The 1st time it also happened but they found out later that the bead was missing.Both times outside the abdomen.No instruments saved and only the lot# of the 2nd time it occured.Patient status: patient is ok.Type of intervention: ni.

Manufacturer Narrative

The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformance's that could have contributed to the reported event.In the absence of the event unit, it is difficult to determine if the reported event was caused by a manufacturing non-conformance or circumstantial factors at the time of use.Applied medical has reviewed the details surrounding the event and is unable to determine the exact 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.

• Brand Name: CD001, 10MM RETRIEVAL SYS, 10BX
• 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: 13904819
• MDR Text Key: 288179962
• Report Number: 2027111-2022-00528
• Device Sequence Number: 1
• Product Code: GCJ
• 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: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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