MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CB040, 5MMX45CM EPIX LAPA SCISSOR, 10/BX; HET

Model Number	CB040
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has just received the incident device and has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of investigation.
Event or Problem Description
Roux-en-y - "blades were not cutting." patient status - "patient is good.".
Additional Manufacturer Narrative
The event unit was returned for evaluation.The shaft of the device was bent in two places and the handle halves had begun to separate.Upon evaluation, engineering noted that the event unit was unable to cut dense material.Further inspection revealed that the blades had sustained damage at the middle of the blade.The root cause of blades not cutting is likely damage sustained due to an effort to cut material that was too hard or dense, such as a staple or clip.The instructions for use (ifu) states, "damage may occur if cutting of clips or staples is attempted".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: CB040, 5MMX45CM EPIX LAPA SCISSOR, 10/BX
• Common Device Name: HET
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6380690
• Report Number: 2027111-2017-01446
• Device Sequence Number: 10921460
• Product Code: HET
• UDI-Device Identifier: 00607915110130
• UDI-Public: (01)00607915110130(17)191025(30)01(10)1282131
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K062169
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2017

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: 10/25/2019
• Device Model Number: CB040
• Device Catalogue Number: 101080402
• Device Lot Number: 1282131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2017
• Supplement Report FDA Received Date: 05/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1