MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTR03, 5X100 KII OPT ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CTR03

Device Problem Insufficient Information (3190)

Patient Problem Bowel Perforation (2668)

Event Date 08/03/2021

Event Type  Injury  

Manufacturer Narrative

No product is being returned to applied medical for evaluation.A follow-up report will be sent upon completion of the investigation.

Event Description

Procedure performed: laparoscopic gastric sleeve.Event description: product is not available for return, the hospital disposed of it after the procedure.Per the surgeon's trocar evaluation form "5mm trocar very hard to insert after veress needle insufflation resulted in colon perforation and conversion to open repair.This was using the visiport technique." applied medical rep was not present for the case.According to hospital staff, and consistent with dr.(b)(6) incident report, it was relayed there was a perforation of the colon which occurred upon visual trocar entry with the optical, non-bladed 5mm trocar.The procedure was converted to open for repair.The patient had no previous abdominal surgeries.The original procedure was postponed, and the patient is reportedly in the hospital recovering as of (b)(6) 2021.Intervention: surgeon converted to open and repaired perforation patient status: patient is reportedly in the hospital recovering as of (b)(6) 2021.They are doing fine.

Event Description

Procedure performed: laparoscopic gastric sleeve event description: product is not available for return, the hospital disposed of it after the procedure.Per the surgeon's trocar evaluation form "5mm trocar very hard to insert after veress needle insufflation resulted in colon perforation and conversion to open repair.This was using the visiport technique." applied medical rep was not present for the case.According to hospital staff, and consistent with dr.[name] incident report, it was relayed there was a perforation of the colon which occurred upon visual trocar entry with the optical, non-bladed 5mm trocar.The procedure was converted to open for repair.The patient had no previous abdominal surgeries.The original procedure was postponed, and the patient is reportedly in the hospital recovering as of (b)(6) 2021.Intervention: surgeon converted to open and repaired perforation patient status: patient is reportedly in the hospital recovering as of (b)(6) 2021.They are doing fine.

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-conformances that could have contributed to the reported event.Applied medical has reviewed the details surrounding the event and related products.At this time, applied medical is unable to determine the cause of the injury or confirm that a product malfunction occurred.The instructions for use (ifu) states, "to minimize the risks associated with access port placement, ensure: appropriate patient positioning to shift organs away from access port placement site.Obturator tip is pointing away from major vessels, organs and other anatomic structures." the probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: CTR03, 5X100 KII OPT ZTHR 6/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: 12294413
• MDR Text Key: 265604265
• Report Number: 2027111-2021-00598
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• PMA/PMN Number: K060096
• 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: 09/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CTR03
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/04/2021
• Initial Date FDA Received: 08/09/2021
• Supplement Dates Manufacturer Received: 08/04/2021
• Supplement Dates FDA Received: 09/28/2021
• Patient Sequence Number: 1
• Treatment: SCOPE; SCOPE
• Patient Outcome(s): Required Intervention