MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-11-30 for MANOSCAN 3890- manufactured by Given Imaging Los Angeles Llc.
[93291614]
To date, the incident sample has not been received for evaluation. If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[93291615]
According to the reporter, their catheter is showing discoloration and corrosion. It is also stated that it was difficult to remove during the last procedure and needed ent assistance after it became lodged against a nasal septal spur. The device will be returned for investigation.
Patient Sequence No: 1, Text Type: D, B5
[115964589]
Evaluation summary: this report will be based on information provided by the tech support. The returned sample met specification as received by manufacturer. The customer reported there is discoloration. The investigation found the catheter passed calibration. The discoloration is visible , but not abnormal. The unit was fully tested and found to meet operational specifications and function normally. This unit does not meet the requirements for a manufacturing or service failure therefore. Information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005344223-2017-05008 |
| MDR Report Key | 7070165 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2017-11-30 |
| Date of Report | 2018-01-31 |
| Date of Event | 2017-11-16 |
| Date Mfgr Received | 2018-01-11 |
| Date Added to Maude | 2017-11-30 |
| 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 | 2034925267 |
| 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 | 2017-11-30 |
| Returned To Mfg | 2017-11-27 |
| 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 | 1. Other | 2017-11-30 |