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

Model Number	CB050
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2016
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.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.There is no report of serious injury or death associated with this event.
Event or Problem Description
Diagnostic laparoscopy - "the monopolar energy transmission delivered from the scissor to the patient was intermittent.They replaced the device and it worked fine." patient status - no patient injury.
Additional Manufacturer Narrative
Investigation summary: the event unit was returned for evaluation.Upon inspection, engineering noted that the distal end of the device was covered in cauterized tissue/debris from the surgery.Testing determined that there was little to no continuity between the monopolar connector and the blades, which confirmed the complainant?s experience.The root cause of the intermittent electro-surgical functionality is cauterized tissue/debris blocking the electrical continuity through the device.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.
Event or Problem Description
Additional information received via email from sales rep on january 16, 2017 - the insufflation settings is typically 12-14 depending on the patient.They were removing peritoneum on the abdomen sidewalls.Scissors are not being re-processed.

• 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: 6224024
• Report Number: 2027111-2017-00007
• Device Sequence Number: 675106
• Product Code: HET
• UDI-Device Identifier: 00607915124519
• UDI-Public: (01)00607915124519(17)180104(30)01(10)1237885
• 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: 01/04/2018
• Device Model Number: CB050
• Device Catalogue Number: 101098801
• Device Lot Number: 1237885
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/04/2017
• Supplement Report FDA Received Date: 05/04/2017
• Patient Sequence Number: 1