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	12/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device is anticipated to return.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: tatme.Evaluation with [ dr] about new gpp+isb+hook.Everything went fine but during cleaning the tip of the hook, tiny part of insulation just ribbed off.I try to clean the hook as much i could and it is now in my car.Cleaning department did not want to clean it "beacuse" it is single use instrument and they did not want to keep it in their department.We decided to take it with us.Patient status: no patient injury or illness did occur associated with the complaint event.Type of intervention: unknown.
Event or Problem Description
Procedure performed: tatme.Evaluation with [ dr] about new gpp+isb+hook.Everything went fine but during cleaning the tip of the hook, tiny part of insulation just ribbed off.I try to clean the hook as much i could and it is now in my car.Cleaning department did not want to clean it beacuse it is single use instrument and they did not want to keep it in their department.We decided to take it with us.Patient status: no patient injury or illness did occur associated with the complaint event type of intervention: unknown.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the tip insulation had detached from the shaft.Based on the condition of the returned unit, the reported event was caused by a modification to the tip of the device.The probability and criticality of harm resulting from this failure 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: 8172083
• Report Number: 2027111-2018-00471
• Device Sequence Number: 1459414
• 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: FI
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 12/04/2018
• 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