MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CNGL3, GELPOINT MINI ADV ACCESS PLATFORM; GCJ

Model Number	CNGL3
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device is anticipated to return.A follow-up report will be provided upon completion of the investigation.
Event or Problem Description
Procedure performed -"laparoscopic bilateral salpingectomy" "[surgeon] conducting a laparoscopic bilateral salpingectomy single site via gelpoint mini.I was not in attendance to the case.The fascia was tagged per the pysician [surgeon] prior to placing the alexis portion of the gelpoint mini.After the alexis was retracted down and gel capped placed ontop of the alexis there was an attempt to establish pneumoperitenium.They were unsuccesful at establishing pneumoperitenium.It was mentioned that no instruments or laprascope were placed down any of the low profile ports prior to the removal of the gel cap.The gel cap was removed and [suregeon] noticed the plastic sheath of the alexis to be tore.All of the product was removed from the patient and set aside.Another gelpoint mini was opened and used with out any issues." type of intervention -"all of the product was removed fromthe patient and set aside.Another gelpoint mini was opened and used with out any issues." patient status -no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed that the sheath was partially attached to the inner ring.Based on the condition of the returned unit, it is likely that the reported event was caused by a combination of the inner ring material and shape.The probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.Applied medical continuously seeks to improve the form, function and ease of use of its products.As part of this process, applied medical is currently researching possible device and/or process enhancements intended to further minimize the potential for this type of event to occur.

• Brand Name: CNGL3, GELPOINT MINI ADV ACCESS PLATFORM
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 7049758
• Report Number: 2027111-2017-02119
• Device Sequence Number: 19282309
• Product Code: GCJ
• UDI-Device Identifier: 00607915131784
• UDI-Public: (01)00607915131784(17)200702(30)01(10)1300433
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K090275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/04/2018

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
• Operator of Device: Other
• Device Expiration Date: 07/02/2020
• Device Model Number: CNGL3
• Device Catalogue Number: 101361901
• Device Lot Number: 1300433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 01/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1