MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,user facility report with the FDA on 2018-08-23 for MANOSCAN FGS-8016 manufactured by Given Imaging Los Angeles Llc.
[118011843]
Occupation: na/other. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[118011844]
The following study investigated the outcomes of patients who underwent peroral endoscopic myotomy for achalasia. Complications that occurred during the surgery included cutaneous emphysema [10/87], mucosal injury [2/87]) and pneumothorax [1/87]. Of the two patients with mucosal injury one was found to have mucosal injury before surgery, and esophageal stent was applied in both patients. As for those with cutaneous emphysema, and pneumothorax, their symptoms were mild and no specific interventions were necessary. No mucosal perforation or delayed bleeding was observed in any of the patients during the esophagogastroduodenoscopy (egd), which was performed 5 days after surgery. Three months after polyneuropathy, organomegaly, endocrinopathy, m-protein (poem), five patients reported heartburn and regurgitation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005344223-2018-00008 |
| MDR Report Key | 7809325 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2018-08-23 |
| Date of Report | 2018-08-23 |
| Date of Event | 2014-01-01 |
| Date Mfgr Received | 2018-08-03 |
| Date Added to Maude | 2018-08-23 |
| 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 | AMY BEEMAN |
| Manufacturer Street | 5920 LONGBOW DRIVE |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal | 80301 |
| Manufacturer Phone | 7632104064 |
| Manufacturer G1 | GIVEN IMAGING LOS ANGELES LLC |
| Manufacturer Street | 5860 UPLANDER WAY |
| Manufacturer City | CULVER CITY CA 90230 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 90230 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MANOSCAN |
| Generic Name | SYSTEM, GASTROINTESTINAL MOTILITY (ELECTRICAL) |
| Product Code | FFX |
| Date Received | 2018-08-23 |
| Model Number | FGS-8016 |
| Catalog Number | FGS-8016 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GIVEN IMAGING LOS ANGELES LLC |
| Manufacturer Address | 5860 UPLANDER WAY CULVER CITY CA 90230 US 90230 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-23 |