MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-05-09 for PNEUMOLINER WA90500US manufactured by Advanced Surgical Concepts Ltd.
[107687869]
The device was not returned for evaluation. Based on asc's investigation of this event to date, which included discussions with the clinical specialist in attendance at the case and the surgeon, asc believes that this event was the result of user error. Because it is unclear whether or the extent to which the pneumoliner caused or contributed to this event, asc is submitting 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
[107687870]
On (b)(6) 2017, asc became aware of the following event involving the pneumoliner (pl). The procedure was a supracervical hysterectomy. It was reported that the surgeon was attempting to grab soft tissue at the base of the pl and inadvertently grabbed the pl and the small bowel as well, with the tenaculum. The surgeon said the pl performed as intended, unrolling and inflating and providing a large space for morcellation. There was a large calcified fibroid which she found very hard to morcellate. The surgeon grabbed the side of the pl along with the tissue, which she noticed when drawing the tissue towards the morcellator. The surgeon could see a 5mm tear in the pl and a loop of small bowel pushing into the pl. The surgeon marked the section of bowel that was damaged, closed off the tear in the pl with a kelly clamp and hand-morcellated the remaining fibroid at the incision site. A general surgeon then made the repair to the section of the bowel that was damaged during the same surgery. The surgeon stated the patient had made a full recovery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616720-2017-00002 |
| MDR Report Key | 7497700 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-05-09 |
| Date of Report | 2017-08-31 |
| Date of Event | 2017-08-29 |
| Date Mfgr Received | 2017-08-31 |
| 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 | 3 |
| Brand Name | PNEUMOLINER |
| Generic Name | LAPAROSCOPIC POWER MORCELLATION CONTAINMENT SYSTEM |
| Product Code | PMU |
| Date Received | 2018-05-09 |
| Model Number | WA90500US |
| Catalog Number | WA90500US |
| Operator | PHYSICIAN |
| Device Availability | N |
| 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 | 1. Required No Informationntervention | 2018-05-09 |