MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8501, S ALEXIS LAP SYS 6/BX; DRAPE, SURGICAL

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	10/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: laparoscopic sigmaresection.Event description: the sheath of the alexis tore when the doctor tried to put the cap on.No one could see why this happened.I was there for the surgery and couldn't see it either.I cleaned the product and took pictures.The hospital kept the product there - in case for investigation.Additional information received from applied medical representative via email on 25-oct-2021: neither the representative nor the surgeon noticed any instrument coming into contact with the sheath.The customer uses this device on a near daily basis, but they never experienced a damaged sheath.Type of intervention: ni.Patient status: patient is ok.
Event or Problem Description
Procedure performed: laparoscopic sigmaresection.Event description: the sheath of the alexis tore when the doctor tried to put the cap on.No one could see why this happened.I was there for the surgery and couldn't see it either.I cleaned the product and took pictures.The hospital kept the product there - in case for investigation.Additional information received from applied medical representative via email on (b)(6)2021: neither the representative nor the surgeon noticed any instrument coming into contact with the sheath.The customer uses this device on a near daily basis, but they never experienced a damaged sheath.Type of intervention: ni.Patient status: patient is ok.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photo of the event unit was provided, confirming the complainant¿s experience of a torn sheath.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: C8501, S ALEXIS LAP SYS 6/BX
• Common Device Name: DRAPE, SURGICAL
• 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: 12704464
• Report Number: 2027111-2021-00690
• Device Sequence Number: 16510841
• Product Code: KKX
• UDI-Device Identifier: 00607915119928
• UDI-Public: (01)00607915119928(17)230722(30)01(10)1391831
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2021

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: 07/22/2023
• Device Model Number: C8501
• Device Catalogue Number: 101042501
• Device Lot Number: 1391831
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 10/27/2021
• Supplement Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2020
• 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