MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CNGL2, GELPOINT ADVANCED ACCESS PLATFORM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CNGL2

Device Problem Difficult to Open or Close (2921)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2019

Event Type  malfunction  

Manufacturer Narrative

Event unit returned for evaluation.A follow-up report will be provided upon completion of the investigation.This report is a follow-up report in response to (b)(4).

Event Description

Name of procedure being performed: total laparoscopic hysterectomy, bilateral salpingectomy an cystoscopy.Limited information received.Rep received a call stating that the "alexis portion of the gelpoint wouldn't open." additional information received from applied medical account manager, via e-mail on july 30th, 2019: "the lot number is 1348003.It is available for return for credit.Please change the hospital contact from [name] to [name].[name] will handle the return.I wasn't able to speak to the surgeon and [name] wasn't aware of the procedure being performed." additional information received from applied medical account manager, via phone on july 30th, 2019 at 15:38 : while the rep didn't know the exact procedure that was being performed, she stated it was some kind of gyn surgery.The rep stated that after the surgeon made an umbilical incision, the purple inner flexible part of the alexis wouldn't open.The alexis was deployed 3 different times and it wouldn't "un taco" and the ring remained in a closed position.The case was completed when the surgeon used another gelpoint as a replacement.There was no patient injury.Additional information received from the fda medwatch form via mail on august 23, 2019: (b)(4).Some basic patient info was provided: 50 year old female who isn't hispanic/latino."describe the event or problem: gelpoint device did not open properly." "partial operative notes: preoperative diagnoses: fibroid uterus and abnormal uterine bleeding.Postoperative diagnoses: fibroid uterus and abnormal uterine bleeding.Procedure: total laparoscopic hysterectomy, bilateral salpingectomy and cystoscopy.Anesthesia: general endotracheal.Specimens: uterus with cervix and bilateral fallopian tubes.Findings: an enlarged multiply fibroid uterus, bilaterally normal ovaries, fallopian tubes, appendix, liver edge on cystoscopy.The patient was status post left nephrectomy, so no urine was seen to pass through the left ureteral orifice." "description of procedure:.Due to the size of the uterus, a port several centimeters above the umbilicus was planned.There were no adhesions to the anterior abdominal wall, so it was felt that a gelport could be accommodated.After transilluminating the abdominal wall, an approximately 3 cm transverse incision was made about 4 finger breadths above the umbilicus.Dissection was carried down to the fascia.The fascia was incised transversely after being grasped with allis clamps.The abdomen was entered and then 0 vicryl sutures were placed on the fascia to aid in later closure.The incision was opened enough to allow the operator to insert 2 fingers.The o-ring of the gelport was inserted and the exterior ring was rotated down.The organ protector was placed and the top of the gelport attached with 3 ports; two 10 mm ports and one 15 mm port.This had to be performed a total of 3 more times because it appeared that each time either omentum or some bowel became included in the anterior ring.Following that, the right would not open evenly and so it was replaced with another gelport and placement was successful.The patient was placed in deep trendelenburg positioning, right and left lower quadrant." "what was the original intended procedure?: cystoscopy [52000 (cpt)], hysterectomy, laparoscopic total (lth) uterus 250 g or less [58570 (cpt)], salpingectomy, laparoscopic [58661 (cpt)], bilateral." "what problem did the user have (check all that apply): device malfunction - that is, the device did not do what it was supposed to do;" patient status: no patient injury.Intervention: replaced with another gelpoint to complete the case.

Manufacturer Narrative

The event unit was returned to applied medical for evaluation.Testing was performed on the event unit.However, the complainant¿s experience could not be replicated or confirmed.Applied medical has reviewed the details surrounding the event and related product and is unable to confirm that a product malfunction occurred, as the event unit met current specifications.This event is not reportable as it is unlikely to cause or contribute to death or serious injury.This report is to follow up medwatch report # (b)(4).

Event Description

Name of procedure being performed: total laparoscopic hysterectomy, bilateral salpingectomy an cystoscopy.Limited information received.Rep received a call stating that the "alexis portion of the gelpoint wouldn't open." additional information received from applied medical account manager, via e-mail on july 30th, 2019: "the lot number is 1348003.It is available for return for credit.Please change the hospital contact from [name] to [name].[name] will handle the return.I wasn't able to speak to the surgeon and [name] wasn't aware of the procedure being performed." additional information received from applied medical account manager, via phone on july 30th, 2019 at 15:38: while the rep didn't know the exact procedure that was being performed, she stated it was some kind of gyn surgery.The rep stated that after the surgeon made an umbilical incision, the purple inner flexible part of the alexis wouldn't open.The alexis was deployed 3 different times and it wouldn't "un taco" and the ring remained in a closed position.The case was completed when the surgeon used another gelpoint as a replacement.There was no patient injury.Additional information received from the fda medwatch form via mail on august 23, 2019: mw # (b)(4).Some basic patient info was provided: 50 year old female who isn't hispanic/latino."describe the event or problem: gelpoint device did not open properly." "partial operative notes: preoperative diagnoses: fibroid uterus and abnormal uterine bleeding.Postoperative diagnoses: fibroid uterus and abnormal uterine bleeding.Procedure: total laparoscopic hysterectomy, bilateral salpingectomy and cystoscopy.Anesthesia: general endotracheal.Specimens: uterus with cervix and bilateral fallopian tubes.Findings: an enlarged multiply fibroid uterus, bilaterally normal ovaries, fallopian tubes, appendix, liver edge on cystoscopy.The patient was status post left nephrectomy, so no urine was seen to pass through the left ureteral orifice." "description of procedure:.Due to the size of the uterus, a port several centimeters above the umbilicus was planned.There were no adhesions to the anterior abdominal wall, so it was felt that a gelport could be accommodated.After transilluminating the abdominal wall, an approximately 3 cm transverse incision was made about 4 finger breadths above the umbilicus.Dissection was carried down to the fascia.The fascia was incised transversely after being grasped with allis clamps.The abdomen was entered and then 0 vicryl sutures were placed on the fascia to aid in later closure.The incision was opened enough to allow the operator to insert 2 fingers.The o-ring of the gelport was inserted and the exterior ring was rotated down.The organ protector was placed and the top of the gelport attached with 3 ports; two 10 mm ports and one 15 mm port.This had to be performed a total of 3 more times because it appeared that each time either omentum or some bowel became included in the anterior ring.Following that, the right would not open evenly and so it was replaced with another gelport and placement was successful.The patient was placed in deep trendelenburg positioning, right and left lower quadrant." "what was the original intended procedure?: cystoscopy [52000 (cpt)], hysterectomy, laparoscopic total (lth) uterus 250 g or less [58570 (cpt)], salpingectomy, laparoscopic [58661 (cpt)], bilateral"."what problem did the user have (check all that apply): device malfunction - that is, the device did not do what it was supposed to do;" patient status: no patient injury.Intervention: replaced with another gelpoint to complete the case.

• Brand Name: CNGL2, GELPOINT ADVANCED ACCESS PLATFORM
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 9098685
• MDR Text Key: 159599037
• Report Number: 2027111-2019-00593
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00607915125325
• UDI-Public: (01)00607915125325(17)220224(30)01(10)1348003
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2022
• Device Model Number: CNGL2
• Device Catalogue Number: 101191201
• Device Lot Number: 1348003
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/16/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OTHER PRODUCTS IN GELPOINT AND ALLIS CLAMPS.
• Patient Age: 50 YR