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 has been assigned to engineering for evaluation.A follow-up report will be sent 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.
Event or Problem Description
Procedure performed unknown - "after the scissor was opened the protective sheath was removed and in the process the insulation tore." type of intervention - "used the pistol grip scissor." patient status - "na".
Additional Manufacturer Narrative
The event unit was returned for evaluation.Upon evaluation, engineering confirmed the complainant's experience of insulation damage.Blood residue and burn marks were noted between the damaged dielectric sleeve and the shaft, indicating that the device and its monopolar function were used inside the patient.This contradicts the complainant's description of the event which stated the damage occurred during removal from packaging.The root cause of the insulation damage is most likely a 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: 6246806
• Report Number: 2027111-2017-00018
• Device Sequence Number: 907613
• Product Code: HET
• UDI-Device Identifier: 00607915124519
• UDI-Public: (01)00607915124519(17)181227(30)01(10)1260313
• 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): 06/21/2017

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: 12/27/2018
• Device Model Number: CB050
• Device Catalogue Number: 101098801
• Device Lot Number: 1260313
• 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: 12/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/12/2017
• Supplement Report FDA Received Date: 06/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1