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

Model Number	8
Medical Device Problem Code	Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/23/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One event unit was returned for evaluation.Upon inspection, engineering tested the unit and was able to replicate the customer experience.The unit was disassembled and damage was observed on the blade post and track.The root cause of the poor cutting experience was due to the damage seen to the blade post and track that allowed the blade post to jump out of the track, not allowing the scissor to close.This can occur when the scissor is used to cut difficult or dense material.During the manufacturing assembly process, all units are 100% functionally inspected.Applied medical will monitor its vigilance system for trends and take further appropriate actions as necessary.This report is being filed as a result of a re-review of applied medical complaints received between june 1, 2014 and may 31, 2016.This retrospective review was associated with a quality management system (qms) compliance action plan developed and presented to fda to address an april 10, 2015 warning letter.Applied medical has revised its mdr reporting criteria to be more conservative and has improved complaint handling and mdr reporting processes.The reviews ensured that recent reportable events were appropriately identified and reported to the designated regulatory authority(ies).This report, which represents the initial and final reports combined, is being submitted based on the findings of that retrospective review.In accordance with 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.
Event or Problem Description
Procedure performed unknown - "scissors cutting deteriorated throughout case where multiple (5-6) fibroids where removed.Dr.Fox continued to use them until they failed to cut at all.It was a long case and he made many cuts with minimal use of the cautery." patient status - good.

• 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: 6382350
• Report Number: 2027111-2017-01403
• Device Sequence Number: 18951266
• Product Code: HET
• UDI-Device Identifier: 00607915124519
• UDI-Public: (01)00607915124519(17)171118(30)01(10)1235276
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: 8
• 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
• Report Date (Section B): 03/06/2017

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: Health Professional
• Device Expiration Date: 11/18/2017
• Device Model Number: 8
• Device Catalogue Number: 8
• Device Lot Number: 1235276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2015
• Initial Report FDA Received Date: 03/06/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1