MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES UNKNOWN

Model Number UNKNOWN

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No product is being returned for evaluation and no lot # has been provided to manufacturer. A final report will be sent once the results have been analyzed.

Event Description

Name of procedure being performed: transanal total mesorectal excision with intersphincteric resection. Detailed description of event: please see for a cer that was recently reported to us. All the information we received has been included; however, as the information we received is relatively limited, we're planning to reach out to dr. [name] to gather more information on the event. [name] spoke with dr. [name] at the [name]. He shared feedback on a robotic case using the gelpoint abdominally and gelpoint path transanally. He said that during the case the inner valve of one of the sleeves detached. Additionally, one of the sleeves pushed through the gel and into the patient. Dr. [name] believes these occurrences were caused by the difficulty of the case and maneuvering the robot. He did not confirm which platform this event occurred with (gelpoint or gelpoint path) and did not state whether any material was left in the patient. The units will not be returned. Type of intervention: ni. Patient status: patient injury or illness did not occur. Unknown.

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. The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.

Event Description

Name of procedure being performed: transanal total mesorectal excision with intersphincteric resection. Detailed description of event: please see attached for a cer that was recently reported to us. All the information we received has been included; however, as the information we received is relatively limited, we¿re planning to reach out to dr. [name] to gather more information on the event. [name] spoke with dr. [name] at the [name]. He shared feedback on a robotic case using the gelpoint abdominally and gelpoint path transanally. He said that during the case the inner valve of one of the sleeves detached. Additionally, one of the sleeves pushed through the gel and into the patient. Dr. [name] believes these occurrences were caused by the difficulty of the case and maneuvering the robot. He did not confirm which platform this event occurred with (gelpoint or gelpoint path) and did not state whether any material was left in the patient. The units will not be returned. Type of intervention: ni. Patient status: patient injury or illness did not occur. Unknown.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• 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: 8641619
• MDR Text Key: 149980339
• Report Number: 2027111-2019-00456
• Device Sequence Number: 1
• Product Code: FER
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 09/10/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 05/01/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial