MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CB010, 5MMX34CM SCISSOR REPOS CRTR 10/BX; HET

Model Number	CB010
Medical Device Problem Code	Torn Material (3024)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/14/2017
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 investigation.There is no report of serious injury or death associated with this event.
Event or Problem Description
Lap chole - as they opened the package, the tip of the blade end of the scissors was ripped (sheath part) and looked a little bit burnt.Rep confirmed with the customer that the device was not re-processed.Type of intervention - na.Patient injury - no patient injury.
Additional Manufacturer Narrative
The event unit was returned for evaluation.Upon evaluation, engineering confirmed that the dielectric sleeve was ripped at the distal end of the unit.The actuation rod was detached from the event unit, the tracks of the actuation rod were damaged, and the cutting edges of the blades were transposed.The root cause of the damage to the dielectric sleeve was determined to be use error.Based on previous testing, improper installation technique of the product would result in a detached actuation rod and then damage the tracks of the actuation rod.This would cause the blades to move freely and damage the dielectric sleeve.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: CB010, 5MMX34CM SCISSOR REPOS CRTR 10/BX
• Common Device Name: HET
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6457223
• Report Number: 2027111-2017-01671
• Device Sequence Number: 16362502
• Product Code: HET
• UDI-Device Identifier: 00607915117320
• UDI-Public: (01)00607915117320(17)191025(30)01(10)1282133
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K040295
• 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: CB010
• Device Catalogue Number: 100810101
• Device Lot Number: 1282133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/04/2017
• Supplement Report FDA Received Date: 05/09/2017
• Patient Sequence Number: 1