MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CNB11, GELPOINT PATH WITH ISB, 5.5CM ANOSCOPE AND ACCESSORIES

Model Number CNB11

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/21/2019

Event Type  malfunction  

Manufacturer Narrative

The event unit was returned to applied medical for evaluation. Visual inspection of the returned unit confirmed the complainant¿s experience of seal component separation. The shield, an internal plastic component of the seal, had separated from the seal. Based on condition of the unit that was returned, the shield most likely dislodged as a result of non-axial insertion or removal of asymmetrical instrumentation through the sleeve. Applied medical's instructions for use (ifu) 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. " this report is a combined initial and follow-up report.

Event Description

Name of procedure being performed: tatme. Detailed description of event: i am reaching out to report a possible product failure in a tatme case at [name] hospital this morning. The product i am reaching out about is ta211 (the gelpoint path w/ l hook) the case began at 8:30 am and ended at 1:00 p. M. The surgeon utilizing the gelpoint path was dr. [name] assisted in the case by dr. [name]. During the case, a small piece of clear plastic appearing to come from a trocar port attached to the gelpoint path came loose and was found in the patient¿s rectum. The surgeon removed the small plastic piece from the port with a grasper. There was no patient harm. Additional information received via email on 25jun2019 from applied medical field assoc: the procedure was a tatme (transanal total mesorectal excision) the device was actually borrowed by [name] hospital from [name] hospital, to have in time for the procedure so that is why you are not finding it. I reached out to my contact[name] for the lot number on the product. She said that their risk management is assessing the situation before she can respond to me, but informed me that there was no patient harm. I will give her a call again tomorrow to get more information. Type of intervention: the surgeon removed the small plastic piece from the port with a grasper. Patient status: there was no harm to the patient.

• Brand Name: CNB11, GELPOINT PATH WITH ISB, 5.5CM
• Type of Device: ANOSCOPE AND ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: wendy kobayashi ; 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138059
• MDR Report Key: 9084499
• MDR Text Key: 159194107
• Report Number: 2027111-2019-00592
• Device Sequence Number: 1
• Product Code: FER
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171701
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 09/18/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: CNB11
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019

Is the Reporter a Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 09/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial