MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C7302, 5MMX33CM EPIX L-HOOK ES PRB 1/EA; GEI

Model Number	C7302
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed: "lc".Patient status: "fine"."this instrument was first used.In surgery, the l-hook tip fell off and surgeon has been removed it from patient body." type of intervention: "removed it from patient body.".
Additional Manufacturer Narrative
Investigation summary: the event unit was returned to applied medical for evaluation.Upon visual inspection, the probe tip was detached and damage was observed on the probe and cautery post.Functional testing could not be performed as the device was returned non-functional.Based on the condition of the returned unit, it is likely that the damage observed was caused by improper handling during use.The instructions for use (ifu) warns the user to "inspect the device for any damage, ensuring there are no unintended sharp edges, rough surfaces or protrusions on the outer surface of the electrosurgical probe which may cause harm.Verify that all parts are in working order.Do not use device if damaged.Discard if the device is bent, nicked, cracked, leaking or otherwise damaged." applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

• Brand Name: C7302, 5MMX33CM EPIX L-HOOK ES PRB 1/EA
• Common Device Name: GEI
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6695622
• Report Number: 2027111-2017-01907
• Device Sequence Number: 1246375
• Product Code: GEI
• UDI-Device Identifier: 00607915127640
• UDI-Public: (01)00607915127640(11)160613(30)01(10)1270618
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: D212132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2017

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: Other
• Device Expiration Date: 06/13/2021
• Device Model Number: C7302
• Device Catalogue Number: 101147301
• Device Lot Number: 1270618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2017
• Supplement Date Received by Manufacturer: 06/30/2017
• Initial Report FDA Received Date: 07/07/2017
• Supplement Report FDA Received Date: 08/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1