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.

Manufacturer Narrative

A sleeve from the event unit was returned to applied medical for evaluation.Visual inspection of the sleeve confirmed that the shield, an internal plastic component of the seal, had partially dislodged within the seal with the shield petals exposed at the top of the cap.Applied medical has reviewed the details surrounding the event and is unable to determine the root cause of the event based on the evaluation of the returned unit and description of the event.This event was initially reported based on the description of the event.However, based on the evaluation of the returned unit, applied medical determined that this event is not reportable as it is unlikely to cause or contribute to death or serious injury.

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]: plastic instrument guide is referring to the trocars as per attached picture.Photo attached.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
• MDR Report Key: 11717051
• MDR Text Key: 247287050
• Report Number: 2027111-2021-00464
• Device Sequence Number: 1
• Product Code: FER
• UDI-Device Identifier: 00607915134440
• UDI-Public: (01)00607915134440(17)211007(30)01(10)1338891
• 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: 06/22/2021

1 Device was Involved in the Event

1 Patient was 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: Health Professional
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GRASPER