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	02/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.A follow-up report will be provided upon the completion of the investigation.
Event or Problem Description
Procedure performed: upper gs surgery laparoscopic robotic esophagectomy.Event description: "this is a complaint from the market.Administrative no.(b)(4).Please refer to the complaint sheet for investigation." "shield fell off" "report from the sales rep: the esophagectomy was performed with da vinci system (version:si).During an insertion of an endoscope for da vinci system, one of the seal components, the transparent valve was removed and it fell off inside the abdomen.All pieces were retrieved and are accounted for.The patient status is ok.Initial investigation report the event unit was returned to us and visually inspected.The shield was removed from the seal.However, the ddb and septum remain assembled with the seal.A petal of the shield was fragmented from the shield.We noted the septum was fragmented.However, the fragment for the missing section on the septum was not returned to us.The unit will be returned to amr for further evaluation.Admin# (b)(4)" cer check list operation time was approximately 5 hours.The surgeon's skill level was "attending/skilled surgeon".Main usage of the damaged trocar was the camera port.The number of insertion/removal during surgery was approximately 10 times.The surgeon and/or nurse found the damage right after the start of the case.The surgeon and/or nurse found the parts during the case.After finding the damage the surgeon removed some of damaged parts.Intraperitoneal irrigation was not performed at the case.This was the first time that the same issue happened at the same department/specialty at the hospital.Type of intervention: "all pieces were retrieved and are accounted for." patient status: no patient injury."the patient status is ok.".
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation, along with a clear fragment.Visual inspection confirmed the complainant's experience of seal component separation.The shield, a clear plastic internal component of the seal, had been dislodged and was missing a piece.The clear fragment matched the missing portion of the shield.The septum, a rubber component of the seal, was observed to be fragmented as well.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.

• 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: 7376141
• Report Number: 2027111-2018-00125
• Device Sequence Number: 11052832
• Product Code: GCJ
• UDI-Device Identifier: 00607915116460
• UDI-Public: (01)00607915116460(17)200813(30)01(10)1303025
• Combination Product (Y/N): N
• PMA/510(K) Number: K060629
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/18/2018

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: Other
• Device Expiration Date: 08/13/2020
• Device Model Number: C0R50
• Device Catalogue Number: 101451901
• Device Lot Number: 1303025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2018
• Supplement Date Received by Manufacturer: 03/01/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1