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

Device Problem Material Rupture (1546)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Procedure performed: robotic myomectomy.Event description: initial information received on 3oct2022: last friday, i had a call with [name] (ireland ¿ territory manager), and it seems that the alexis ces gen 2 was misused.I don¿t know the details, but it seems that the surgeon didn¿t use the guard or the retractor and the ces bag was cut during the manual morcellation.The case happened at the end of (b)(6), at the (b)(6).The device used was gtk 14 (probably).Information received upon completion of the complaint form on (b)(6) 2022: performing a robotic myomectomy and was trying to perform the excite technique.Confusion over exactly on how she wanted use the alexis ces did not want to use the guard as it was restricting her ability to access the fibroid to perform the excite technique.She was having severe difficulty in performing the actual excite technique as she experienced consistent slippage with the toothed graspers in use.And the small size of the incision.Therefore the actual excite technique was not performed correctly.Patient status: no patient injury has been reported.Type of intervention: ni.

Event Description

Procedure performed: robotic myomectomy.Event description: initial information received on 3oct2022: last friday, i had a call with [name] (ireland ¿ territory manager), and it seems that the alexis ces gen 2 was misused.I don¿t know the details, but it seems that the surgeon didn¿t use the guard or the retractor and the ces bag was cut during the manual morcellation.The case happened at the end of july, at the [facility].The device used was gtk 14 (probably).Information received upon completion of the complaint form on 5oct2022: performing a robotic myomectomy and was trying to perform the excite technique.Confusion over exactly on how she wanted use the alexis ces did not want to use the guard as it was restricting her ability to access the fibroid to perform the excite technique.She was having severe difficulty in performing the actual excite technique as she experienced consistent slippage with the toothed graspers in use.And the small size of the incision.Therefore the actual excite technique was not performed correctly.Additional information received from applied medical representative via email 15dec2022: the only codes ordered and placed on the shelf in [facility] are the gtk14 and gtk17.Also, these are the only alexis contained extraction systems used by [doctor name redacted] when she was performing the excite technique.They were the original code of the alexis ces contained extraction system with kii balloon blunt tip access system not the gen 2 with the tether on the bag and with alexis wound protector /retractor combined.The code did not change from gen 1 to gen 2.Patient status: no patient injury has been reported.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-conformances 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: UNKNOWN
• 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: 15601958
• MDR Text Key: 307268034
• Report Number: 2027111-2022-00777
• Device Sequence Number: 1
• Product Code: GCJ
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/09/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/30/2022
• Initial Date FDA Received: 10/13/2022
• Supplement Dates Manufacturer Received: 09/30/2022
• Supplement Dates FDA Received: 01/09/2023
• 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
• Treatment: ROBOT, TOOTHED GRASPERS