MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2017-09-21 for MANOSCAN 3890- manufactured by Given Imaging Los Angeles Llc.
[86980662]
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[86980663]
According to the reporter, the catheter has a sharp edge where the sensor portion meets the white cable, and is showing an issue on channel 26 during the procedure. The device will be returned for investigation. Patient experienced minor bleeding in the nasal cavity, and was sent to the ear, nose and throat department. The last known patient status is good.
Patient Sequence No: 1, Text Type: D, B5
[112632758]
This report is based on information provided by the complaint tracking system. No product was received. This device has been used in the treatment or diagnosis of a patient. The sample did not meet specification. The picture sample showed a catheter fails calibration and showing error in several sensors. The customer reported the device has a sharp edge where sensor portion meets white cable. And also noticed issues on (b)(6) during procedures. Without the sample a detailed investigation could not be performed. If additional information is obtained, or the sample is returned, we will re-open this investigation. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005344223-2017-05007 |
| MDR Report Key | 6883917 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2017-09-21 |
| Date of Report | 2018-01-08 |
| Date of Event | 2017-08-31 |
| Date Mfgr Received | 2017-12-19 |
| Date Added to Maude | 2017-09-21 |
| 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 | SHARON MURPHY |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 2034925297 |
| 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 | 2017-09-21 |
| Returned To Mfg | 2017-09-06 |
| Model Number | 3890- |
| Catalog Number | 3890- |
| 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 | 2017-09-21 |