MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES GTB14, ALEXIS CES 14CM 3/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number GTB14

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Laceration(s) (1946)

Event Type  Injury  

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 investigation.

Event Description

Procedure performed: ni event description: "button straps ripped vaginal wall of elderly patient.No value" additional information was received via email on 24mar2023 from account manger i, applied medical when asked questions for additional information the rep responded: "this was info from the scrub nurse therefore i unfortunately do not have any of these answers as i was not in the case of spoke to the surgeon.If i work with the surgeon or see this during a case i will file a formal complaint.This was simply feedback that the strap was said to not be of value." product not available for return.Additional information was received via email on 11apr2023 from clinical development, applied medical unfortunately, no.[name] got back to me with the same information that she has no information and viewed the submission as feedback.The surgeon is no responsive intervention: ni patient status: 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-conformances that could have contributed to the reported event.The complainant did not allege any malfunction with an applied medical device.According to subject matter experts, surgeons who are familiar with the device, it is unlikely that the event unit caused the vaginal lacerations.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.

Event Description

Procedure performed: ni.Event description: "button straps ripped vaginal wall of elderly patient.No value" additional information was received via email on 24mar2023 from account manger i, applied medical when asked questions for additional information the rep responded: "this was info from the scrub nurse therefore i unfortunately do not have any of these answers as i was not in the case of spoke to the surgeon.If i work with the surgeon or see this during a case i will file a formal complaint.This was simply feedback that the strap was said to not be of value." product not available for return.Additional information was received via email on 11apr2023 from clinical development, applied medical unfortunately, no.[name] got back to me with the same information that she has no information and viewed the submission as feedback.The surgeon is no responsive intervention: ni.Patient status: ni.

• Brand Name: GTB14, ALEXIS CES 14CM 3/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: 16792358
• MDR Text Key: 313803238
• Report Number: 2027111-2023-00420
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: GTB14
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/22/2023
• 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
• Patient Outcome(s): Other