MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-05-09 for PNEUMOLINER WA90500US manufactured by Advanced Surgical Concepts Ltd.
[108251839]
Based on discussion with the clinical specialist (cs) as part of asc's investigation into this event, the company understands that the trocars were not removed and the surgeon used a zero degree endoscope. Trocar removal and endoscope requirement is covered in physician training and is addressed in the ifu. Based on the company's investigation, this event appears to be due to user error. Although it is unclear whether such a malfunction would be likely to cause or contribute to a death or serious injury if it were to recur, asc is filing this mdr out of an abundance of caution to ensure full compliance with 21 cfr part 803.
Patient Sequence No: 1, Text Type: N, H10
[108251840]
On (b)(6) 2017, asc received a complaint that the pneumoliner (pl) containment device ripped or came apart during a laparoscopic supracervical hysterectomy. The physician continued the power morcellation with the ripped pl in use. The cs informed asc that the surgeon did not remove the trocars as per the training prior to deflation of the abdomen. Therefore, the pl did not inflate fully. Warning number 6 in the ifu states: "the pneumoliner must be fully inflated (12 - 15mmhg) to minimize the risk of damage to the bag and adjacent organs during morcellation. " the cs noted a hole in the pl during the case. The surgeon attempted to remove the pl by pulling on the pl with a large amount of force. As there was still too much tissue remaining in the pl to exit the incision, the tear/hole in the pl was propagated due to the large force exerted by the surgeon. This resulted in the remaining contents of the pl spilling into the patient's abdomen and the pl exiting the incision. Asc spoke with surgeon on (b)(6) 2017. The surgeon informed asc he had some difficulty getting the pl to unroll. He stated there was plenty of space to morcellate but he was uncertain if it was fully deployed. He was using a zero degree endoscope. The pl ifu and training clearly state a minimum of a 30-degree scope is required to perform a contained morcellation. The surgeon said he was well into the morcellation when there was a failure. It is unclear what caused the tear in the pl. The tear in the pl was propagated when the surgeon attempted to remove it with excess tissue still remaining to be morcellated. The device was returned to the distributor for evaluation. The inspection clearly identified the hole that was made by the surgeon. The company believes the information provided by the cs and the inspection of the returned device is sufficient to evaluate the complaint.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616720-2017-00001 |
| MDR Report Key | 7497699 |
| Date Received | 2018-05-09 |
| Date of Report | 2017-08-22 |
| Date of Event | 2017-08-11 |
| Date Mfgr Received | 2017-08-22 |
| Device Manufacturer Date | 2016-07-19 |
| Date Added to Maude | 2018-05-09 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR EDWARD HYLAND |
| Manufacturer Street | UNIT 4, SUNNYBANK CENTER UPPER DARGLE ROAD |
| Manufacturer City | BRAY, COUNTY WICKLOW A98 E339 |
| Manufacturer Country | EI |
| Manufacturer Postal | A98 E339 |
| Manufacturer G1 | DIELECTRICS INC. |
| Manufacturer Street | 300 BURNETT ROAD |
| Manufacturer City | CHICOPEE MA 01020 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01020 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | PNEUMOLINER |
| Generic Name | LAPAROSCOPIC POWER MORCELLATION CONTAINMENT SYSTEM |
| Product Code | PMU |
| Date Received | 2018-05-09 |
| Model Number | WA90500US |
| Catalog Number | WA90500US |
| Lot Number | 999102 |
| Device Expiration Date | 2019-07-19 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED SURGICAL CONCEPTS LTD |
| Manufacturer Address | UNIT 4, SUNNYBANK CENTER UPPER DARGLE ROAD BRAY, COUNTY WICKLOW A98 E339 EI A98 E339 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-05-09 |