MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8701, S ALEXIS LAP SYS W/KII FIOS 5/BX; DRAPE, SURGICAL

Model Number	C8701
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned to applied medical for evaluation but lot # is provided.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
Name of procedure being performed: urological procedure detailed description of event: cer 1 of 2: (b)(4), cer 2 of 2: (b)(4).When inserting the alexis, the product was undamaged.After removing the cap later, a tear was found in the sheath.According to the customer, this happened once before on (b)(6) 2021 with a product from the same lot#.None of the products were kept for investigation.The first time the tear was along from the green placement ring about 7cm towards the white ring, then the second time along the green ring (circular).The customer cannot explain how and when the tearing occurred, whether it was a user error or product defect.He says it could be that the white ring was rolled in too many times to create maximum retraction.After consultation, the product was properly applied for an incision size between 2.5-6cm.They needed to replace the product for this procedure.The patient was ok.Patient status: good, no consequences for the patient.Type of intervention: change of device.
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.
Event or Problem Description
Name of procedure being performed: urological procedure detailed description of event: cer 1 of 2: 2021-001718; cer 2 of 2: 2021-001719.When inserting the alexis, the product was undamaged.After removing the cap later, a tear was found in the sheath.According to the customer, this happened once before on 12.07.21 with a product from the same lot#.None of the products were kept for investigation.The first time the tear was along from the green placement ring about 7cm towards the white ring, then the second time along the green ring (circular).The customer cannot explain how and when the tearing occurred, whether it was a user error or product defect.He says it could be that the white ring was rolled in too many times to create maximum retraction.After consultation, the product was properly applied for an incision size between 2.5-6cm.They needed to replace the product for this procedure.The patient was ok.Patient status: good, no consequences for the patient.Type of intervention: change of device.

• Brand Name: C8701, S ALEXIS LAP SYS W/KII FIOS 5/BX
• Common Device Name: DRAPE, SURGICAL
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 12281804
• Report Number: 2027111-2021-00594
• Device Sequence Number: 14390509
• Product Code: KKX
• UDI-Device Identifier: 00607915125714
• UDI-Public: (01)00607915125714(17)231118(30)01(10)1400548
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2021

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: 11/18/2023
• Device Model Number: C8701
• Device Catalogue Number: 101473672
• Device Lot Number: 1400548
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/16/2021
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 09/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1