MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CNB10, GELPOINT PATH WITH ISB, 4CM; FER

Model Number CNB10

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Skin Tears (2516)

Event Type  malfunction  

Manufacturer Narrative

The event unit will not return to applied medical.A follow-up report will be provided upon completion of the investigation.

Event Description

Name of procedure being performed: transanal total mesorectal excision.Detailed description of event: [name] spoke with dr.[name] at the society for american gastrointestinal and endoscopic surgeons (sages).He shared feedback on the new gelpoint path models and detailed a case using cnb10 that caused patient injury.After completing a tatme on a small female, dr.[name] removed the platform and noticed a tear in the mucosa of the anal canal.He sutured the tear immediately and believes it was caused by the channel being too wide for the patient.The timeline for this occurrence is uncertain as it was reported to an applied team member at a surgical congress.The unit will not be returned.Concomitant device: ni.Patient status: stable, injury corrected at time of event.

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.In the absence of the event unit, it is difficult to determine the exact root cause of the event.Applied medical has reviewed the details surrounding the event and related products.At this time, applied medical is unable to determine the cause of the injury or confirm that a product malfunction occurred.Applied medical will monitor its vigilance systems for any developing trends.

Event Description

Name of procedure being performed: transanal total mesorectal excision.Detailed description of event: [name] spoke with dr.[name] at the society for american gastrointestinal and endoscopic surgeons (sages).He shared feedback on the new gelpoint path models and detailed a case using cnb10 that caused patient injury.After completing a tatme on a small female, dr.[name] removed the platform and noticed a tear in the mucosa of the anal canal.He sutured the tear immediately and believes it was caused by the channel being too wide for the patient.The timeline for this occurrence is uncertain as it was reported to an applied team member at a surgical congress.The unit will not be returned.Additional info received form associate clinical development specialist on april 16, 2019 via email: "the product will not be returned.Also, would you be able to help me change the model number from cnb10 to cno11?" concomitant device: ni.Patient status: stable, injury corrected at time of event.

• Brand Name: CNB10, GELPOINT PATH WITH ISB, 4CM
• Type of Device: FER
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida emprsa; rancho santa margarita CA 92688
• MDR Report Key: 8520657
• MDR Text Key: 142181553
• Report Number: 2027111-2019-00424
• Device Sequence Number: 1
• Product Code: FER
• Combination Product (y/n): N
• PMA/PMN Number: K171701
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CNB10
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other