MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CW002, 5MMX42CM EPIX ES SMK EVAC ANG LHK; GEI

Model Number	CW002
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation but lot # is provided.A device history report is to be reviewed by engineering.A final report will be sent once the results have been analyzed.
Event or Problem Description
Procedure performed: tatme.(b)(4) was created for device 1.(b)(4) was created for device 2.At the beginning of 2 procedures, before the usage, the insulation on top, just right before the l, was detached from the rest of the shaft.The surgeon realized the damage right after the scrub tech passed the probe.The surgeon decided to keep using the material and actually was really happy with the performance of the product during the whole tatme.The energy used was cut 45 and coag 50.Both samples were disposed after the usage.Patient status: patient did not occur injury.Type of intervention: the surgeon decided to keep using the material.
Event or Problem Description
Cer 2018-101133 was created for device 1 cer 2018-101134 was created for device 2 at the beginning of 2 procedures, before the usage, the insulation on top, just right before the l, was detached from the rest of the shaft.The surgeon realized the damage right after the scrub tech passed the probe.The surgeon decided to keep using the material and actually was really happy with the performance of the product during the whole tatme.The energy used was cut 45 and coag 50.Both samples were disposed after the usage.
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.Although the event unit was not returned, a photo was provided by the customer.Visual inspection confirmed that the tip insulation had detached from the shaft.Based on the description of the event and the photo provided by the customer, the reported event was caused by a modification to the tip of the device.The probability and criticality of harm resulting from this failure mode have been evaluated and were found to be at an acceptable level.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical is currently researching possible product enhancements intended to further minimize the potential for this type of event to occur.Recall number: 2027111-12/06/18-001-r.

• Brand Name: CW002, 5MMX42CM EPIX ES SMK EVAC ANG LHK
• Common Device Name: GEI
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 8172108
• Report Number: 2027111-2018-00476
• Device Sequence Number: 16634440
• Product Code: GEI
• UDI-Device Identifier: 00607915136147
• UDI-Public: (01)00607915136147(17)210912(30)01(10)1336418
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K171684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2019

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: 09/12/2021
• Device Model Number: CW002
• Device Catalogue Number: 101470783
• Device Lot Number: 1336418
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/26/2018
• Supplement Date Received by Manufacturer: 11/26/2018
• Initial Report FDA Received Date: 12/17/2018
• Supplement Report FDA Received Date: 02/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1