MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8323, XXS ALEXIS WND PROT/RET SHRT 5/BX; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number	C8323
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure performed: vats description of event: complaint 1 of 3: (b)(4), model c8401 lot 1506767 1ea.Complaint 2 of 3: (b)(4), model c8323 lot 1524616 1ea.Complaint 3 of 3: (b)(4), model unknown lot unknown 1ea.[hospital] 3 alexis device malfunctions occurred during the same procedure.The first alexis' sheath tore as soon as they placed the device and folded the ring.Half of the sheath fell off the ring entirely.A second alexis was opened, however this device's sheath tore near the attachment to the ring.A third alexis was opened, however this device's sheath entirely disconnected from the ring as they moved the specimen through it.A fourth alexis was opened and used to complete the case.There was no patient injury.The rep was not present at the case.There are no photos available of the devices.The product is not available for return.Additional information received from account manager via email on 26aug2024: it is unknown what instruments were being used within the alexis.According to the scrub person, the sheath tore on the white ring for the alexis o and tore on the side for the alexis xxs.Alexis o, size s, lot #1506767 and alexis xxs, lot #1524616 were the complaint devices.The product was discarded by the hospital.The sheath did not particulate to the rep's knowledge.It is unknown what the model and lot number was for the third alexis malfunction.Additional information received from account manager via email on 28aug2024: the second alexis tore at the ring during the procedure.Intervention: a fourth device was opened and used to complete the case.Patient status: no patient injury.
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: vats.Description of event: complaint 1 of 3: (b)(4).Model c8401 lot 1506767 1ea.Complaint 2 of 3: (b)(4).Model c8323 lot 1524616 1ea - mfr 2027111-2024-00831.Complaint 3 of 3: (b)(4).Model unknown lot unknown 1ea - mfr 2027111-2024-00832.[hospital] 3 alexis device malfunctions occurred during the same procedure.The first alexis' sheath tore as soon as they placed the device and folded the ring.Half of the sheath fell off the ring entirely.A second alexis was opened, however this device's sheath tore near the attachment to the ring.A third alexis was opened, however this device's sheath entirely disconnected from the ring as they moved the specimen through it.A fourth alexis was opened and used to complete the case.There was no patient injury.The rep was not present at the case.There are no photos available of the devices.The product is not available for return.Additional information received from account manager via email on 26aug2024: it is unknown what instruments were being used within the alexis.According to the scrub person, the sheath tore on the white ring for the alexis o and tore on the side for the alexis xxs.Alexis o, size s, lot #1506767 and alexis xxs, lot #1524616 were the complaint devices.The product was discarded by the hospital.The sheath did not particulate to the rep's knowledge.It is unknown what the model and lot number was for the third alexis malfunction.Additional information received from account manager via email on 28aug2024: the second alexis tore at the ring during the procedure.Intervention: a fourth device was opened and used to complete the case.Patient status: no patient injury.
Additional 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.Applied medical has performed a historical trend analysis and review of production records and no relevant documentation was identified.

• Brand Name: C8323, XXS ALEXIS WND PROT/RET SHRT 5/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: 20263279
• Report Number: 2027111-2024-00831
• Device Sequence Number: 18191808
• Product Code: KGW
• UDI-Device Identifier: 00607915132941
• UDI-Public: (01)00607915132941(17)270517(30)01(10)1524616
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2024

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 Model Number: C8323
• Device Catalogue Number: 101478546
• Device Lot Number: 1524616
• 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: 08/22/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/17/2024
• 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
• Patient Sex: Unknown