MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-01-08 for PNEUMOLINER WA90500US manufactured by Advanced Surgical Concepts Ltd..
[174148912]
Sus voluntary event report (# mw5091187) was filed in the medsun database (fda maude).
Patient Sequence No: 1, Text Type: N, H10
[174148913]
The pneumoliner bag had been damaged during surgery by grasping the tissue specimen and the bag and engaging the power morcellator. The surgical technician noticed and the procedure was stopped. The surgeon confirmed there was no viscera damage and it was only the pneumoliner bag that had been breached. Some pieces of the fibroid tissue spilled into the abdominal cavity. These were picked out; no fragments were left in the patient. The surgical technician noticed a small piece of the bag was missing. The surgical team did everything they could to locate the small piece of bag material. They flushed the abdominal cavity with 2l of saline. They flushed saline through the lena morcellator and they examined the morcellated tissue but were unable to locate the missing piece of the bag. They also performed an x-ray on the patient as this was hospital protocol. This report is being raised as a patient injury due to the unknown location of the specimen bag fragment and the possibility that it remained in the patient. Although it is unlikely whether such an event resulting in a small piece of polyurethane material, would be likely to cause or contribute to a death or serious injury if it were to recur, asc is filing this medwatch report out of an abundance of caution to ensure full compliance with 21 cfr part 803. The pathology report shows the patient was cancer free. There was no injury to the patient from use of the device. The patient reported no adverse reaction.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616720-2019-00002 |
| MDR Report Key | 9564294 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-01-08 |
| Date of Report | 2020-01-08 |
| Date of Event | 2019-11-14 |
| Date Mfgr Received | 2019-11-14 |
| Date Added to Maude | 2020-01-08 |
| 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 1&4, SUNNYBANK CENTER UPPER DARGLE ROAD |
| Manufacturer City | BRAY, CO. 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 | 2020-01-08 |
| Model Number | WA90500US |
| Catalog Number | WA90500US |
| Lot Number | 113202 |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED SURGICAL CONCEPTS LTD. |
| Manufacturer Address | UNIT 1&4, SUNNYBANK CENTER UPPER DARGLE ROAD BRAY, A98 E339 EI A98 E339 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2020-01-08 |