MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-06-11 for MANOSCAN 3890 manufactured by Given Imaging Los Angeles Llc.
[110730443]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[110730444]
According to the reporter, the probe got stuck in patient for 2 hours. It took 2 hours to remove probe from the patient. The customer stated that patient had pain and told that it might have been the flex harness that has caused the issue. Nothing was prescribed for pain, a spray was prescribed for potential bleeding. Technical support explained to them that the flex harness keep the sensor aligned. The customer said that the probe calibrated just fine. There was no problem with insertion, at the first attempt to remove? It jerked back? And no obstruction was visible, just a little bleeding. The catheter was stuck at 40cm. There was no reported patient outcome.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005344223-2018-00005 |
| MDR Report Key | 7587121 |
| Report Source | USER FACILITY |
| Date Received | 2018-06-11 |
| Date of Report | 2018-06-11 |
| Date of Event | 2018-05-24 |
| Date Mfgr Received | 2018-05-24 |
| Date Added to Maude | 2018-06-11 |
| 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 | 2018-06-11 |
| Model Number | 3890 |
| Catalog Number | 3890 |
| 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 | 2018-06-11 |