MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CNGL2, GELPOINT ADVANCED ACCESS PLATFORM; GCJ

Model Number CNGL2

Device Problem Material Perforation (2205)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

The event device is anticipated to return.A follow-up report will be provided upon completion of investigation.

Event Description

Gel point advanced access platform ref cngl2 internal white ring of the device fell into the abdomen of the patient during the laparoscopy.Ring retrieved.Customer reference: (b)(4)." type of intervention: retrieval of fallen part.Patient status: (b)(6).

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Visual inspection confirmed the complainant's experience of seal component separation.The shield, a clear plastic internal component of the sleeve, was dislodged and was damaged.The septum, a rubber component of the seal, was also fragmented.Based on the condition of the returned unit, it is likely that the reported event was caused by non-axial insertion of an instrument or an asymmetrical instrument that was used during the procedure.The instructions for use (ifu) states that "extra care should be used when inserting angular and asymmetrical instruments, such as 'j' hooks and clip appliers," and "all instruments should be centered axially when inserted through the seal for easier insertion." applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

Event Description

Additional information received from the team member by email on 31 may 18: the event occur during procedure.The device was not removed and replaced.How large the incision was is unknown.

• Brand Name: CNGL2, GELPOINT ADVANCED ACCESS PLATFORM
• Type of Device: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7617648
• MDR Text Key: 111913669
• Report Number: 2027111-2018-00189
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915125325
• UDI-Public: (01)00607915125325(17)191018(30)01(10)1278282
• Combination Product (y/n): N
• PMA/PMN Number: K090275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/18/2019
• Device Model Number: CNGL2
• Device Catalogue Number: 101191201
• Device Lot Number: 1278282
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/23/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 05/23/2018
• Supplement Dates FDA Received: 07/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1