MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFR03, 5X100 KII OPT ADVFIX 6/BX; GCJ

Model Number	CFR03
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/16/2017
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 the investigation.
Event or Problem Description
Procedure performed - "unknown" "this is a complaint from the market.(b)(4).Please refer to the complaint sheet for investigation." "report from the sales rep: the customer had a reservation about potential fragmentation from 3 event units during a procedure.The fragment was not returned due to an inspection in other manufacture's products.Instead, the picture was sent to us.Aside form 3 event units, any applied medical devices were not used during a procedure.Some clip appliers and trocars of [competitor] were used.Initial investigation report: three(3) event units were returned to us and visually inspected.Instead of the whitish fragment(the size is unknown), its picture was sent to us.No damage was observed with the event units.The balloons were successfully inflated to prove that no damage is in the balloons.Please note that since we received the customer's demand to promptly identify source of the fragment, the balloon inflation tests were specially conducted to prove that no damage is in the balloons.The units will be returned to amr for further evaluation.(b)(4).Request: please identify whether or not the fragment was from the applied medical trocars".Additional information received via email from the distributor on july 11, 2017 - only three (3) applied medical trocars (cfr03-lot#1276890) were used, and no other applied medical devices were involved in the procedure.Three (3)ea of cfr03 will be returning, but it is unknown if the piece came from the trocars or if it came from one of the other devices(non-applied medical brand).Olympus would like us to evaluate if the piece came from one of our trocars.Patient status - "no patient injury.".
Additional Manufacturer Narrative
Three event units were returned to applied medical for evaluation.The clear fragment from the event description was not returned for evaluation, but a photo was provided.Upon visual inspection, engineering did not observe any damage or fragmentation to the seal or its internal components and all units met current specifications.Based on the description of the event, the photo that was provided, and the products that were used, it is highly unlikely that the fragment came from an applied medical trocar.It is likely the fragment originated from the non-applied medical devices that were also used during the procedure.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: CFR03, 5X100 KII OPT ADVFIX 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6737566
• Report Number: 2027111-2017-01913
• Device Sequence Number: 13944988
• Product Code: GCJ
• UDI-Device Identifier: 00607915119881
• UDI-Public: (01)00607915119881(17)190823(30)01(10)1276893
• Combination Product (Y/N): N
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2017

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: 08/23/2019
• Device Model Number: CFR03
• Device Catalogue Number: 101288701
• Device Lot Number: 1276893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2017
• Supplement Date Received by Manufacturer: 07/03/2017
• Initial Report FDA Received Date: 07/24/2017
• Supplement Report FDA Received Date: 08/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1