MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES C0R50, 12X130 KII BALLOON BLNT TIP 6/BX; GCJ

Model Number	C0R50
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2017
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: "da vinci si tap inguinal hernia." event description: no incident description was initially provided for the event.Information was received via email from territory manager on monday 04 dec 2017: "the patient was discharged with no injury.I have not been able to get any further details other than it was used as the camera port for the dr vinci." additional information was received via email from territory manager on tuesday 05 dec 2017: "per the customer, they were running the 8.5 mm davinci camera through the trocar and piece of the black seal broke off in the patient.They were able to retrieve it." type of intervention: unknown.Patient status: "the patient was discharged with no injury.".
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of seal component separation.Based on the condition of the returned unit and the description of the event, it is likely that the reported event was caused by non-axial insertion or removal of asymmetrical instruments through the trocar.Applied medical's instructions for use states that, "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers.All instruments should be centered axially when inserted through the seal to prevent tearing." 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 the follow up medwatch report # (b)(4).
Event or Problem Description
Additional information received via mail on 04jan2018 from fda for medwatch # (b)(4) as reported by risk management specialist, at (b)(6): "during a robotic assisted procedure, the physician observed that there were broken pieces of the kii balloon blunt tip system's inner black cannula that had fallen into the abdomen.The physician was able to remove all of the pieces.The broken product was saved." original procedure was robotic assisted si laparoscopic transabdominal preperitoneal bilateral inguinal hernia repair with mesh.Device failed (e.G.Broke, couldn't get it to work or stopped working) patient is a (b)(6), not hispanic/latino.Type of intervention: "the physician was able to remove all of the pieces.".

• Brand Name: C0R50, 12X130 KII BALLOON BLNT TIP 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7105462
• Report Number: 2027111-2017-02149
• Device Sequence Number: 1874192
• Product Code: GCJ
• UDI-Device Identifier: 00607915116460
• UDI-Public: (01)00607915116460(17)200803(30)01(10)1302171
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K060629
• 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): 01/15/2018

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: 08/03/2020
• Device Model Number: C0R50
• Device Catalogue Number: 101451901
• Device Lot Number: 1302171
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 01/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Weight: 103