MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CB050, 5X38CM EPIX INLINE SCISSORS 10/BX; HET

Model Number	CB050
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ra has received the incident device and the product has been assigned to engineering for evaluation.A follow-up report will be sent upon completion of the investigation.
Event or Problem Description
Unknown procedure - "after the scissor was opened the protective sheath was removed and in the process the insulation tore." patient status - n/a.
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering confirmed that the insulation was torn/lacerated.It was noted the presence of a burn mark in the center and deepest part of the laceration.The root cause of the torn insulation is most likely due to the reusable trocar that was used during the procedure.Engineering determined that a small burr on the reusable trocar would be capable of damaging the dielectric sleeve in a similar manner as seen on the event unit.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: CB050, 5X38CM EPIX INLINE SCISSORS 10/BX
• Common Device Name: HET
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6353713
• Report Number: 2027111-2017-01514
• Device Sequence Number: 19015910
• Product Code: HET
• UDI-Device Identifier: 00607915124519
• UDI-Public: (01)00607915124519(17)190722(30)01(10)1275440
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 05/04/2017

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: 07/22/2019
• Device Model Number: CB050
• Device Catalogue Number: 101098801
• Device Lot Number: 1275440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2017
• Supplement Report FDA Received Date: 05/04/2017
• Patient Sequence Number: 1