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	11/27/2018
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.During the case the scrub nurse noticed the small black rubber just before the l detached.This insulating part was detached from its base; however it could be fixed by pushing it toward the shaft with two fingers.This issue didn't affect the evacuation performance or the monopolar features.The surgeon didn't even notice that.The cleaning method was with a wet gauze; no excessive pressure was notice during that procedure, although in the first part of the procedure the hook was cleaned more frequently.Indeed during the mucosa incision the more eschar was noticed than in the mesorectal dissection.Settings of the monopolar, 60 cut.The green sheath has been always put over the l tip to protect during the insertion or extraction from the trocar.Also i noticed the tip was bent and the green sheath couldn't cover the tip till the end, so the nurse pushed it back in place and it worked well.I asked for the sample, but when they went to put in a plastic bag, i saw they put in a decontaminating pool, then it "has been" washed.Not sure if this "affect" the engineering test.Patient status: no patient injury.Type of intervention: unknown.
Event or Problem Description
Procedure performed: tatme.During the case the scrub nurse noticed the small black rubber just before the l detached (see the picture).This insulating part was detached from its base, however it could be fixed by pushing it toward the shaft with two fingers.This issue didn't affect the evacuation performance or the monopolar features.The surgeon didn't even notice that.The cleaning method was with a wet gauze, no excessive pressure was notice during that procedure, although in the first part of the procedure the hook was cleaned more frequently.Indeed during the mucosa incision the more eschar was noticed than in the mesorectal dissection.Settings of the monopolar, 60 cut.The green sheath has been always put over the l tip to protect during the insertion or extraction from the trocar.Also i noticed the tip was bent and the green sheath couldn't cover the tip till the end, so the nurse pushed it back in place and it worked well.I asked for the sample, but when they went to put in a plastic bag, i saw they put in a decontaminating pool, then it has been washed.Not sure if this affect the engineering test.Patient status: no patient injury.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: 8172070
• Report Number: 2027111-2018-00469
• Device Sequence Number: 11082617
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/27/2018
• Supplement Date Received by Manufacturer: 11/27/2018
• 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