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 2019-04-16 for MANOSCAN 1286 manufactured by Given Imaging Los Angeles Llc.
[142502605]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[142502606]
According to the reporter, the catheter's tpe had a hole near the metal ring at the marker 47-48, but it worked correctly during a previous procedure. The probe got stuck in the patient due to a raised edge where the sensors join with the rest of the probe. The catheter was removed without any intervention required. There was no patient or user harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005344223-2019-00006 |
| MDR Report Key | 8519401 |
| Report Source | FOREIGN,USER FACILITY |
| Date Received | 2019-04-16 |
| Date of Report | 2019-06-26 |
| Date of Event | 2019-03-25 |
| Date Mfgr Received | 2019-06-06 |
| Device Manufacturer Date | 2017-12-15 |
| Date Added to Maude | 2019-04-16 |
| 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 | 161 CHESHIRE LANE, SUITE 100 |
| Manufacturer City | PLYMOUTH MN 55441 |
| Manufacturer Country | US |
| Manufacturer Postal | 55441 |
| 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 | 2019-04-16 |
| Returned To Mfg | 2019-04-15 |
| Model Number | 1286 |
| Catalog Number | 1286 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2019-04-16 |