MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C8501, S ALEXIS LAP SYS 6/BX; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number	C8501
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit returned 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: na.Detailed description of event: all from medical leaders incoming inspection im#20-02app/po#20-03app: c8501 - tear in duckbill.Patient status: na.Type of intervention: na.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed that the valve of the laparoscopic cap had a tear.Based on the condition of the returned unit, the valve of the event unit was unintentionally cut during the manufacturing process.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.A tear in the valve of the laparoscopic cap in not reportable as it is unlikely to cause or contribute to death or serious injury.The event was reported based on the event description and prior to evaluating the returned unit.
Event or Problem Description
Name of procedure being performed: na.Detailed description of event: all from medical leaders incoming inspection (b)(4): c8501 - tear in duckbill.Patient status: na.Type of intervention: na.

• Brand Name: C8501, S ALEXIS LAP SYS 6/BX
• Common Device Name: RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9861243
• Report Number: 2027111-2020-00430
• Device Sequence Number: 2874728
• Product Code: KGW
• UDI-Device Identifier: 00607915119928
• UDI-Public: (01)00607915119928(17)221222(30)01(10)1377540
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

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: No Information
• Device Expiration Date: 12/22/2022
• Device Model Number: C8501
• Device Catalogue Number: 101042501
• Device Lot Number: 1377540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/26/2020
• Supplement Date Received by Manufacturer: 02/26/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1