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

Model Number	CNGL3
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon visual inspection, engineering confirmed that the sheath had partially delaminated from the ring.The sheath was visually inspected for cuts and rips, but no damage was observed.Although the exact root cause of the reported event could not be determined, 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 process enhancements intended to further minimize the potential for this type of event to occur.
Event or Problem Description
Procedure performed: total laparoscopic hysterectomy."the gelpoint mini was placed at the beginning of the procedure and placed correctly (alexis wasn't rolled down extremely tight, trocars were introduced through the gel cap before being placed on the alexis).Both [sales manager] and myself were present and supporting the device in the case (along with the alexis contained extraction system).The other trocars (advanced fixation and z-thread) were placed in the patients abdomen according to surgeon preference.The case started as normal with insufflation on one on the af ports.There were 2 trocars (12mm and 10mm) in the gelpoint which were utilised for the scope (10mm), harmonic, gyrus bipolar and grasper.During the laparoscopic start of the case (before tissue extraction or introduction of containment bag) it was noticed by the consultants that the gelpoint mini was quite loose (not firm against the abdomen when first placed).[it was] suggested that the gel cap could be removed in order to roll the alexis down some more, which was done and the case continued (it was noted that there was more gas being used than usual).Once the specimen was mobilised, the alexis contained extraction system was introduced.The specimen was placed inside the bag (made more difficult by escaping gas).It could also be seen that there was loose plastic, which was initially thought to be from the containment bag, but was later found to be from the green inner ring of the alexis.The specimen was manually morcellated with the gas on, which showed there was a leak.This was thought to be possibly a hole in the bag, but later discovered the bag was whole.After the specimen was removed, the gel cap was placed back on the alexis in order to suture the vaginal vault.This could not be achieved because no gas could remain inside the abdomen".Type of intervention: it was decided to replaced the alexis with a new one, which allowed for the procedure to be completed.Patient status: did a patient injury or illness occur associated with the complaint event? no.

• 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: 7713018
• Report Number: 2027111-2018-00247
• Device Sequence Number: 1384279
• Product Code: GCJ
• UDI-Device Identifier: 00607915131784
• UDI-Public: (01)00607915131784(17)210117(30)01(10)1316011
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K090275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2018

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: Health Professional
• Device Expiration Date: 01/17/2021
• Device Model Number: CNGL3
• Device Catalogue Number: 101361901
• Device Lot Number: 1316011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 07/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1