MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a study report with the FDA on 2019-04-02 for NANOKNIFE SYSTEM UNKNOWN manufactured by Angiodynamics, Inc.
[140660097]
This medwatch is not to report a device malfunction, but to report an adverse patient effect. There was no report of a device malfunction or patient complication during the procedure. It was reported that the disposable device is not available to be returned to the manufacturer for evaluation. An investigation results will be sent via a follow up medwatch. Complaint # (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[140660098]
This medwatch is not to report a device malfunction, but to report an adverse patient effect. There was no report of a device malfunction or patient complication during the procedure. (b)(6) study (nanoknife - pancreatic cases): post-operative course was complicated by an ileus. The patient had return of bowel function on post-op day #6. Her ng tube was removed and she was started on a clear liquid diet with ensure clear supplements. Complaint investigation is warranted since the relationship to the study procedure is related to the device as assessed by the sae. This resulted in medical or surgical intervention to prevent permanent impairment to body structure or function. It was reported the defective disposable device is not available for return to the manufacturer as it was disposed of by the user.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1319211-2019-00025 |
| MDR Report Key | 8474753 |
| Report Source | STUDY |
| Date Received | 2019-04-02 |
| Date of Report | 2019-07-29 |
| Date of Event | 2018-11-09 |
| Date Mfgr Received | 2019-03-07 |
| Date Added to Maude | 2019-04-02 |
| 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 | LAW RYAN |
| Manufacturer Street | 10 GLENS FALLS TECHNICAL PARK |
| Manufacturer City | GLENS FALLS NY 12801 |
| Manufacturer Country | US |
| Manufacturer Postal | 12801 |
| Manufacturer Phone | 5187424488 |
| Manufacturer G1 | ANGIODYNAMICS, INC |
| Manufacturer Street | 603 QUEENSBURY AVENUE |
| Manufacturer City | QUEENSBURY NY 12804 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 12804 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NANOKNIFE SYSTEM |
| Generic Name | LOW ENERGY DIRECT CURRENT ABLATION SYSTEM, |
| Product Code | OAB |
| Date Received | 2019-04-02 |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIODYNAMICS, INC |
| Manufacturer Address | 603 QUEENSBURY AVENUE QUEENSBURY NY 12804 US 12804 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-04-02 |