MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CTB03 OR CTB73

Device Problem Retraction Problem (1536)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The event unit will not be returned to applied medical for evaluation.A follow-up report will be submitted upon completion of investigation.

Event Description

Procedure performed: unknown.Event description: the event date is unknown.Email has implied a previous event (two issues) where the kii threaded bladed trocar has not functioned correctly for unknown reasons and it is also unknown when this happened.These event are recorded in applied medical reference numbers 2019-002112 and 2019-002113.Below email received on (b)(6) 2019 from user facility rep: "now i am afraid than mr [name] has had two issues with the trocars.They have not retracted.One caused slight bowel damage and resulted in him raising it as a safety issue.I appreciate that mr [name] refused training, refused to have you in his theatre and indeed, was not pleasant went you tried to speak to him." patient status: no injury occured.

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 the complainant's experience could not be confirmed or replicated.In the absence of the event unit, it is difficult 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.

Event Description

Procedure performed: unknown.Event description: the event date is unknown.Email has implied a previous event (two issues) where the kii threaded bladed trocar has not functioned correctly for unknown reasons and it is also unknown when this happened.These event are recorded in applied medical reference numbers (b)(4) (report # 2027111-2019-00577) and (b)(4) (report # 2027111-2019-00578).Below email received on 21st august 2019 from user facility rep: "now i am afraid than mr [name] has had two issues with the trocars.They have not retracted.One caused slight bowel damage and resulted in him raising it as a safety issue.I appreciate that mr [name] refused training, refused to have you in his theatre and indeed, was not pleasant went you tried to speak to him." patient status: no injury occured.

• Brand Name: UNK
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8962195
• MDR Text Key: 158803841
• Report Number: 2027111-2019-00578
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K072674
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CTB03 OR CTB73
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2019
• Patient Sequence Number: 1