MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-04 for INSUFFLATOR TUBING SET TM6000 manufactured by Advanced Medical Design Co., Ltd.
[137004735]
Patient Sequence No: 1, Text Type: N, H10
[137004736]
Describe the event or problem: during use the insufflation tubing occiuded. What was the original intended procedure? : lap appy. What problem dld the user have? Device malfunction that is, the device did not do what it was supposed to do.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010570913-2019-00001 |
| MDR Report Key | 8300630 |
| Date Received | 2019-02-04 |
| Date of Report | 2019-01-24 |
| Date of Event | 2018-12-31 |
| Date Facility Aware | 2019-01-24 |
| Report Date | 2019-01-24 |
| Date Reported to Mfgr | 2019-01-24 |
| Date Added to Maude | 2019-02-04 |
| 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 | MR. ARNOLD YEH |
| Manufacturer Street | 4F-5F, NO29, WUQUAN 5TH RD WUGU DIST |
| Manufacturer City | NEW TAIPEI CITY, 24888 |
| Manufacturer Country | TW |
| Manufacturer Postal | 24888 |
| Manufacturer G1 | ADVANCED MEDICAL DESIGN CO., LTD |
| Manufacturer Street | 4F-5F, NO29, WUQUAN 5TH RD WUGU DIST |
| Manufacturer City | NEW TAIPEI CITY, 24888 |
| Manufacturer Country | TW |
| Manufacturer Postal Code | 24888 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | INSUFFLATOR TUBING SET |
| Generic Name | INSUFFLATOR TUBING SET |
| Product Code | NKC |
| Date Received | 2019-02-04 |
| Model Number | TM6000 |
| Lot Number | 1727955 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ADVANCED MEDICAL DESIGN CO., LTD |
| Manufacturer Address | 4F-5F, NO29, WUQUAN 5TH RD WUGU DIST NEW TAIPEI CITY, 24888 TW 24888 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-04 |