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

Model Number CNB10

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

The event unit returned to applied medical for evaluation.A follow-up report will be provided upon completion of the investigation.

Event Description

Name of procedure being performed: teo.Detailed description of event: hospital: [name] hospital.The inner valve of the access channel fell out before inserting the gelpoint path into the patient's rectum.Used another access channel as replacement.Patient status: no patient injury.Type of intervention used another access channel as replacement.

Event Description

Name of procedure being performed: teo detailed description of event: hospital: [name] hospital the inner valve of the access channel fell out before inserting the gelpoint path into the patient's rectum.Used another access channel as replacement.Patient status: no patient injury type of intervention used another access channel as replacement.

Manufacturer Narrative

A sleeve from the event unit was returned to applied medical for evaluation.Visual inspection of the returned unit confirmed that the shield, an internal plastic component of the seal, had separated from the seal.Engineering also observed scratches on the shield and a tear on the septum, an internal rubber component of the seal.Based on condition of the returned unit, it is likely that the reported event was caused by 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.".

• Brand Name: CNB10, GELPOINT PATH WITH ISB, 4CM
• Type of Device: ANOSCOPE AND ACCESSORIES
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 10368355
• MDR Text Key: 201775581
• Report Number: 2027111-2020-00523
• Device Sequence Number: 1
• Product Code: FER
• UDI-Device Identifier: 00607915137915
• UDI-Public: (01)00607915137915(17)221022(30)01(10)1372651
• Combination Product (y/n): N
• PMA/PMN Number: K171701
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/22/2022
• Device Model Number: CNB10
• Device Catalogue Number: 101472124
• Device Lot Number: 1372651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1