MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CNGL2, GELPOINT ADVANCED ACCESS PLATFORM; RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL

Model Number CNGL2

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2020

Event Type  malfunction  

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering determined that the gelseal cap and sleeves were confirming.Engineering also observed that there were three (3) tears in the sheath.Based on the condition of the returned unit, the leak was caused the tears that were observed in the sheath.It is likely the sheath tear was caused by the instrumentation that was used during the procedure.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.This report is a combined initial and follow-up report.

Event Description

Name of procedure being performed: abdominal total hysterectomy.Detailed description of event: hospital: [name].Air leak occurs between gelseal cap and sleeves.Additional information received via email on 10aug2020 from [name]: the leakage occurred "after 15 minutes later." the leaking was noted when the trocars were being manipulated in the gel.The surgeon inserted a 10mm scope, 5mm grapser through the gelseal cap.The leak appeared to be at the interface between the trocar and gel of the gelseal cap.The surgeon did not place and remove the trocars at several points on the gel.They replaced with a new one to complete the case.Patient status: fine.Type of intervention: they replaced with a new one.

• Brand Name: CNGL2, GELPOINT ADVANCED ACCESS PLATFORM
• Type of Device: RING (WOUND PROTECTOR), DRAPE RETENTION, INTERNAL
• 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: 10687466
• MDR Text Key: 223451657
• Report Number: 2027111-2020-00584
• Device Sequence Number: 1
• Product Code: KGW
• UDI-Device Identifier: 00607915125325
• UDI-Public: (01)00607915125325(17)220307(30)01(10)1349516
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K090275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2022
• Device Model Number: CNGL2
• Device Catalogue Number: 101191201
• Device Lot Number: 1349516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1