MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF04, KII 5X100 FIOS Z-TH HN 6/BX; GCJ

Model Number	1
Medical Device Problem Code	Bent (1059)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device has been returned and assigned to engineering for evaluation.A follow-up report will be sent upon completion of the investigation.Based on the description of the event during initial intake of the complaint, the event was not reportable as it was unlikely to cause or contribute to death or serious injury.Upon closer inspection of the returned unit, the event is now deemed reportable due to fragmentation of the obturator shaft and fractured cannula.This report is to follow up medwatch #(b)(4).
Event or Problem Description
Procedure performed: lap gastric sleeve (non-robotic).Incident description: the trocar bent during first entry while using the fios technique, the sales reps was informed that the obturator was inside the cannula when the malfunction occurred.Applied medical received additional information via email from territory manager on (b)(4) 2017: the dr.Was performing a lap gastric sleeve (non-robotic) and using the ctf04 for the fios first entry technique.As he was inserting the trocar, it bent in half (obturator still inside).The bent trocar was removed and a new one was used.No parts were left inside the patient and no injury occurred.Medwatch received 12apr2017 - event description: during a laparoscopic sleeve gastrectomy procedure, the obturator with sleeve bent during insertion into the patient.Type of intervention: an additional trocar was used.Patient status: no patient injury.
Additional Manufacturer Narrative
The event product was returned to applied medical for evaluation with two (2) sterile units.No damage was observed on the sterile units.Upon visual inspection of the event unit, engineering was able to confirm that the cannula and obturator were both bent and cracked.The wall thicknesses of the cannula and obturator were measured and were found to be within specifications.Based on similar events, it is likely that the cannula and obturator were bent due to high insertion forces.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 #(b)(4).

• Brand Name: CTF04, KII 5X100 FIOS Z-TH HN 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6494201
• Report Number: 2027111-2017-01710
• Device Sequence Number: 885184
• Product Code: GCJ
• UDI-Device Identifier: 00607915123567
• UDI-Public: (01)00607915123567(17)191011(30)01(10)1281311
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: 1
• 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): 05/10/2017

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: 10/11/2019
• Device Model Number: 1
• Device Catalogue Number: 1
• Device Lot Number: 1281311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/14/2017
• Supplement Report FDA Received Date: 05/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Patient Weight: 91