|
ETHICON ENDO-SURGERY, LLC. OPT BLADELESS 5X100 STABILITY; LAPAROSCOPE, GENERAL AND PLASTIC SURGERY
|
Back to Search Results |
|
| Model Number 2B5LT |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
| Patient Problems
Death (1802); Tissue Damage (2104); Blood Loss (2597); No Code Available (3191)
|
| Event Date 12/10/2019 |
|
Event Type
Death
|
|
Manufacturer Narrative
|
|
(b)(4).Batch # unk.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Attempts are being made to obtain the following information and the device: please describe the patient¿s positioning at insertion of the trocar? was the trocar port a primary port or a secondary port? if primary port, was it placed by using an endoscope? if secondary port, was insertion visualized via an endoscope in the port that was already placed? what was the bmi of the patient? did the surgeon rotate the trocar during insertion? was any traction placed on the abdominal wall during trocar insertion? how was the bleeding initially identified? where was the bleeding identified during the first laparotomy? how was the bleeding addressed or treated during this first laparotomy? why was the patient rushed back to surgery from the recovery room? how was the bleed identified and repaired during the second laparotomy? approximately how much blood did the patient lose? was the patient given any blood products and if so, how many units? was patient¿s hospitalization extended beyond what is normally expected (and if so, how long was patient hospitalized)? what is the patient¿s current status? does the surgeon believe the trocar malfunctioned in any way, leading to the negative patient outcome? to date no response has been provided and no device has been received.If the device or further details are received at a later date, a supplemental medwatch will be sent.
|
| |
|
Event Description
|
|
It was reported that during a lap chole ,a bladeless trocar was inserted on an un-insufflated abdomen and bleeding was noticed.A laparotomy was performed and the bleeding was stopped.Then the patient was in recovery and was rushed back to "theatre" (surgery).Another laparotomy was performed and a bleed was identified in the aorta at the bi-furcation with the iliac vessels.A vascular surgeon was called, patient was operated on for 11 hours, and was transferred to hospital.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).Date sent: (b)(6)2020.H10=corrected data=h1 h1: type of reportable event: is now death as additional information was received reporting that the patient has died.H2: additional information was requested and the following information was received: please describe the patient¿s positioning at insertion of the trocar? lying supine on the operating table was the trocar port a primary port or a secondary port? this was the primary port if primary port, was it placed by using an endoscope? yes it was used as a visual entry, being watched on the monitor if secondary port, was insertion visualized via an endoscope in the port that was already placed? n/a as this was the primary port what was the bmi of the patient? the patient was 77 and quite slim.Not sure of bmi, but it could have been as low as 20 did the surgeon rotate the trocar during insertion? yes the trocar was inserted using rotatory movement was any traction placed on the abdominal wall during trocar insertion? some traction was used by applying one littlewood forceps to the inferior margin of the supraumblical port incision to support the umbilical scar how was the bleeding initially identified? through the laparoscopic camera inserted at the time of insertion of the trocar (visual entry), minimal negligible blood, then afterwards in the pelvis during the initial diagnostic laparoscopy that happens following gas insufflation where was the bleeding identified during the first laparotomy? blood collected in the pelvis how was the bleeding addressed or treated during this first laparotomy? exploration of the retroperitoneum by a longitudinal incision along the great vessels to explore.This revealed intact ivc, some clots and no active bleeding.The small tear seen in the retroperitoneal covering peritoneum was on the right side overlying the area of the ivc.As there was no active ooze and no apparent bleeding from the aorta, the adventitial coverings were not dissected.After 20 minutes observation period and with bp over 100 systolic, the posterior peritoneum was closed over 2 small haemostatic swabs and a large drain left in the pelvis after thorough wash showed no obvious bleeding.Why was the patient rushed back to surgery from the recovery room? deterioration of bp and appearance of 50 mls of blood in the pelvic drain how was the bleed identified and repaired during the second laparotomy? re exploration and re-opening the retroperitoneum, packing, then calling for a vascular surgeon approximately how much blood did the patient lose? during the first operation at least 1 litre, possibly up to 1.5 litres.During the second laparotomy and the prolonged repair and revascularization of left common iliac artery, which necessitated re-doing the repair to avoid stopping the blood flow to the left leg possibly 3 litres was the patient given any blood products and if so, how many units? i think about 24 units of whole blood and 6-8 units of ffp was patient¿s hospitalization extended beyond what is normally expected (and if so, how long was patient hospitalized)? yes for 3 days, until she died from multi-organ failure on day 3 what is the patient¿s current status? deceased does the surgeon believe the trocar malfunctioned in any way, leading to the negative patient outcome? i did not use excessive force at all while inserting the trocar (visually, using the laparoscopic camera).As a matter of fact, because of resistance, possibly from the skin incision, possibly from the cranial side of the umbilical scar, the trocar was removed, skin incision enlarged slightly and the trocar was inserted again (visually again) it entered quickly and very easily inside.The extent of the injury was very surprising considering that i have been doing this operation for 29 years using the same technique without any vascular or organ injuries at all.The trocar was inspected after the operation (retrieved and photographed by the nurse assisting in the operation) and it showed serrated edge on one side of near the tip (but not at the tip itself), raising the possibility that a defective trocar may have been sharper than usual attempts are being made to obtain the following additional information: was an angled scope or zero-degree scope used for insertion of primary port? if an angled scope was used, what was the degree of scope used? what was the height and weight of the patient? what was the previous surgical history for the patient? what was the patient¿s date of death? to date, no response has been provided.If further details are received at a later date, a supplemental medwatch will be sent.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).Date sent: 6/12/2020.H10=corrected data: h6: patient codes: tissue damage added.H2: additional information received: additional information was requested and the following was received: was an angled scope or zero-degree scope used for insertion of primary port? 0 degree scope.If an angled scope was used, what was the degree of scope used? what was the height and weight of the patient?159cm and 59kg.What was the previous surgical history for the patient? no previous abdominal surgery what was the patient¿s date of death?(b)(6) 2019.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).D4: batch # t94k4n.Investigation summary: the analysis results found that the 2b5lt device was returned with no damage in the external components.During functional testing, the obturator advanced through the skin test media without any anomalies noted.The event described could not be confirmed as the device performed without any difficulties noted.The reported complaint could not be confirmed.A manufacturing record evaluation was performed for the finished device batch number and no non-conformances were identified.
|
| |
|
Manufacturer Narrative
|
|
(b)(4).Date sent: 7/1/2020.H2: additional information received: additional information was received on 6/2/2020 that reports "the primary port was a 12mm trocar, 2b12lt." h10=corrected data=h1.H1: mdr decision is now not reportable.In a prior (2nd) follow-up report for 3005075853-2020-00147, which was submitted on 4/21/2020, the trocar port of issue was reported as the primary port, but no product code was provided at that time.Upon review of the additional information received on 6/2/2020 that the trocar port of issue has now been confirmed as a 2b12lt primary port, it was concluded that this event for the 2b5lt device, reported under 3005075853-2020-00147, no longer meets the fda defined criteria for a reportable event and is now being considered not reportable.The reportable event for the device of issue (the primary port with product code of 2b12lt) has been reported under report number 3005075853-2020-00145.
|
| |
|
Search Alerts/Recalls
|
|
|
