MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF03, 5X100 KII FIOS Z-THR 6/BX; GCJ

Model Number CTF03

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 05/14/2018

Event Type  malfunction  

Manufacturer Narrative

No product is being returned for evaluation.A follow-up report will be provided upon completion of the investigation.This report is to follow up medwatch report (b)(4).

Event Description

Procedure performed: laparoscopic surgery event description: cer 1 of 2: (b)(4) (this report), cer 2 of 2: (b)(4) (medwatch no.2027111-2018-00205)."scrub tech was opening trocars to set up the mayo.When he put the obturator into the cannula he noticed that there was some extraneous plastic shavings visible in the tip.He noticed it in the second trocar as well.The account pulled the trocars (never touched a patient) and sequestered all trocars with the same lot number." medwatch received via mail on 12jun2018: (b)(4): describe the event or problem: "while preparing the trocar for use during surgery, the operating room staff noted debris in the trocar.A second trocar was obtained and the second trocar had the same debris.Both trocars had the same lot number.The lot number was pulled from the shelves, and a different lot number was obtained.The debris was inside the clear plastic trocar obturator and appeared to resemble spiraled plastic shreds.Neither trocar had interacted with patient.There was no patient harm." what was the original intended procedure? laparoscopic surgery what problem did the user have (check all that apply): other; patient status: unaffected.Caught before case started.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of plastic shavings.Engineering also observed the presence of scratch marks on the inside of the obturator.Based on the condition of the returned unit, it is likely that the reported event was caused by a sharp or angled or instrument that scraped against the inside wall of the obturator.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.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.This report is to follow up medwatch report # 3302260000-2018-8008.

Event Description

Additional information was received via email on 06/19/2018 from clinical quality coord: "the patient had surgery on (b)(6), not (b)(6).".

• Brand Name: CTF03, 5X100 KII FIOS Z-THR 6/BX
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: wendy kobayashi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138059
• MDR Report Key: 7651801
• MDR Text Key: 113197320
• Report Number: 2027111-2018-00204
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915123550
• UDI-Public: (01)00607915123550(17)210130(30)01(10)1315959
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K041795
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/30/2021
• Device Model Number: CTF03
• Device Catalogue Number: 101138401
• Device Lot Number: 1315959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1