MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8501, S ALEXIS LAP SYS 6/BX; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number	C8501
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation, but lot number is provided.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: lap.Resection rectopexy.Description of event: the alexis was placed into an extended trocar incision, the outer retraction ring was rolled several times outwards for retraction, then the cap was placed onto the outer extraction ring and trocar has been inserted through the cap.When trying to reestablish pneumoperitoneum a leakage was detected.When looking for the source the alexis sheath was identified as the problem.The material had a large almost 180° rift.No clinical impact to the patient, there was only a loss of time.The surgeon extracted the alexis lap.System, ligated the fascia and reinserted a trocar through a small leftover gap.No other instruments used- the surgeon also pointed out that no sharp instruments could have caused the damage.Images available in attachments.Information received from applied medical representative via email 21nov23: the surgeon used a reusable trocar without obturator.The insufflation-pressure was set to 12 mmhg.It was a first incision.No sutures or staples, no previous surgeries.Type of intervention: the surgeon extracted the alexis lap.System, ligated the fascia and reinserted a trocar through a small leftover gap.Patient status: patient wasn't harmed due to the product failure.
Event or Problem Description
Procedure performed: lap.Resection rectopexy description of event: the alexis was placed into an extended trocar incision, the outer retraction ring was rolled several times outwards for retraction, then the cap was placed onto the outer extraction ring and trocar has been inserted through the cap.When trying to reestablish pneumoperitoneum a leakage was detected.When looking for the source the alexis sheath was identified as the problem.The material had a large almost 180° rift.No clinical impact to the patient, there was only a loss of time.The surgeon extracted the alexis lap.System, ligated the fascia and reinserted a trocar through a small leftover gap.No other instruments used- the surgeon also pointed out that no sharp instruments could have caused the damage.Images available in attachments.Information received from applied medical representative via email (b)(6): the surgeon used a reusable trocar without obturator.The insufflation-pressure was set to 12 mmhg.It was a first incision.No sutures or staples, no previous surgeries.Type of intervention: the surgeon extracted the alexis lap.System, ligated the fascia and reinserted a trocar through a small leftover gap.Patient status: patient wasn't harmed due to the product failure.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, photos of the event unit were provided.Visual inspection confirmed the complainant¿s experience of sheath tear.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.

• Brand Name: C8501, S ALEXIS LAP SYS 6/BX
• Common Device Name: RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: farah azmi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138710
• MDR Report Key: 18302898
• Report Number: 2027111-2023-00834
• Device Sequence Number: 6783727
• Product Code: KGW
• UDI-Device Identifier: 00607915119928
• UDI-Public: (01)00607915119928(17)260314(30)01(10)1483065
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/14/2026
• Device Model Number: C8501
• Device Catalogue Number: 101042501
• Device Lot Number: 1483065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 11/15/2023
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 03/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: REUSABLE TROCAR.
• Patient Sex: Unknown