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 Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit is anticipated to return to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Name of procedure being performed: ni detailed description of event: "event: during the surgical procedure after placement of the alexis in the abdomen with its cap, we realized that there was a co2 leak.The cap is removed and it is observed that the separating alexis has broken, so that the co2 escapes through the abdomen." product is available for return.Patient status: "no harm to patient was reported" type of intervention ni.
Event or Problem Description
Detailed description of event: "event: during the surgical procedure after placement of the alexis in the abdomen with its cap, we realized that there was a co2 leak.The cap is removed and it is observed that the separating alexis has broken, so that the co2 escapes through the abdomen." product is available for return.Additional information received via email on 25feb2021 from [name]: "the damage was noted on the body of the alexis (photo attached)" it is unknown if any instruments were used within the alexis.The case was completed by using "another device with the same reference." a photo has been provided.Patient status: "no harm to patient was reported".
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed that there was a tear in the sheath.Based on the condition of the returned unit, it is likely the reported event was caused by an instrument that came into contact with the sheath during the procedure.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: 11340269
• Report Number: 2027111-2021-00338
• Device Sequence Number: 11802882
• Product Code: KKX
• UDI-Device Identifier: 00607915125721
• UDI-Public: (01)00607915125721(17)230306(30)01(10)1382698
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2021

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: 03/06/2023
• Device Model Number: C8702
• Device Catalogue Number: 101135901
• Device Lot Number: 1382698
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/22/2021
• Supplement Date Received by Manufacturer: 01/22/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 20 YR