MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CNO11, GELPOINT PATH, 5.5CM ANOSCOPE AND ACCESSORIES

Model Number CNO11

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2021

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: tatme case. Hospital: [name}. Gelpoint point path was used for a tatme case. During the case, surgeon tried to remove a grasper from the 10mm sleeve, it also drags out the plastic instrument guide. A 4th piece was introduced. Half way through the surgery, the surgeon tried to remove the grasper again for cleaning but the plastic instrument guide was dragged out again. In the end, circulating nurse had to open another piece of sleeves from [name] (new box). Additional information received via email on 06apr2021 from [name]: patient status: no patient injury. Type of intervention: a new piece was opened.

• Brand Name: CNO11, GELPOINT PATH, 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: 11717051
• MDR Text Key: 247287050
• Report Number: 2027111-2021-00464
• Device Sequence Number: 1
• Product Code: FER
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K171701
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/07/2021
• Device Model Number: CNO11
• Device Catalogue Number: 101424301
• Device Lot Number: 1338891
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 03/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial