MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8702, M ALEXIS LAP SYS W/KII FIOS 5/BX; DRAPE, SURGICAL

Model Number	C8702
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation but lot number is provided.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed: left anterior resection.Detailed description of event: dr [name] was using the device towards the end of the procedure.Insertion was fine, the device was utilised for reattachment.The cap put back on.Towards the end of the procedure when the device was being used for visualisation, dr [name] noticed the rip in the plastic.He was concerned that it had torn off in the patient.He was pulling the device up strongly when in use.Patient status: patient is unaffected - surgery complete.Type of intervention: ni.
Event or Problem Description
Name of procedure being performed: left anterior resection detailed description of event: dr [name] was using the device towards the end of the procedure.Insertion was fine, the device was utilised for reattachment.The cap put back on.Towards the end of the procedure when the device was being used for visualisation dr [name] noticed the rip in the plastic.He was concerned that it had torn off in the patient.He was pulling the device up strongly when in use.Additional photos available in attachments.Patient status: patient is unaffected - surgery complete.Type of intervention: ni.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.However, a photograph of the event unit was provided by the complainant.The photograph confirmed 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 related product and is unable to determine the root cause at this time.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

• Brand Name: C8702, M 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: 11881955
• Report Number: 2027111-2021-00507
• Device Sequence Number: 3710464
• Product Code: KKX
• UDI-Device Identifier: 00607915125721
• UDI-Public: (01)00607915125721(17)231221(30)01(10)1404236
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 06/28/2021

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: 12/21/2023
• Device Model Number: C8702
• Device Catalogue Number: 101135901
• Device Lot Number: 1404236
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/06/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 05/25/2021
• Supplement Report FDA Received Date: 06/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1