MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CFB73, 12X100 KII SH BLD ADVFIX 6/BX; GCJ

Model Number	CFB73
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	08/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product is being returned for evaluation but the lot # is provided.A follow-up report will be provided upon completion of investigation.
Event or Problem Description
Procedure performed: laparoscopic appendectomy.Event description: translation: "on friday, (b)(6), a (b)(6) years old patient was admitted for a laparoscopic appendectomy procedure.It was supplied a kit of trocar composed by 1 trocar of 12mm and 2 trocars of 5mm.On the first port, the physician proceeds to insert the 12mm trocar using a hasson technique, without the peritoneum, at the moment when the obturator was removed the sleeve started to filled with blood, after that, they insufflate and put the 5mm trocars on 2 ports.They noticed a massive bleeding, aspirate the blood without decreasing volume; therefore, they decided to proceed turning into an open surgery.Injuries provoked were damage on cava and mesentery." type of intervention: unk.Patient status: translation: "stable, intermediate therapy".
Additional Manufacturer Narrative
The event unit was not returned to applied medical for evaluation.As the event unit was not returned, testing was unable to be performed and the complainant's experience could not be replicated or confirmed.Based on the description of the event, the complainant did not allege any product malfunction.The likely root cause of the reported event is use error.The instruction for use states, "to minimize the risks associated with access port placement, ensure an adequate level of insufflation prior to port placement [and] obturator tip is pointing away from major vessels, organs and other anatomic structures[.]" applied medical has reviewed the details surrounding the event and related products.At this time, applied medical is unable to determine the exact cause of the injury or confirm that a product malfunction occurred.Applied medical will monitor is vigilance systems for any developing trends.

• Brand Name: CFB73, 12X100 KII SH BLD ADVFIX 6/BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6845652
• Report Number: 2027111-2017-01994
• Device Sequence Number: 1522840
• Product Code: GCJ
• UDI-Device Identifier: 00607915117634
• UDI-Public: (01)00607915117634(17)200221(30)01(10)1290028
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K083638
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Expiration Date: 02/21/2020
• Device Model Number: CFB73
• Device Catalogue Number: 101245901
• Device Lot Number: 1290028
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2017
• Supplement Date Received by Manufacturer: 08/22/2017
• Initial Report FDA Received Date: 09/06/2017
• Supplement Report FDA Received Date: 09/20/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention