MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-07-24 for SLK-6-LF SMART BAND LIGATION KIT manufactured by Intelligent Endoscopy.
[114934602]
The band was not returned to olympus for evaluation. The cause of the reported event cannot be determined. However, the instruction manual warns users to? Visually inspect with particular attention to kinks, bends and breaks. If abnormality is detected that would prohibit proper working condition, do not use.?
Patient Sequence No: 1, Text Type: N, H10
[114934603]
Olympus was informed that a patient sustained trauma to the larynx and upper esophageal center after undergoing a therapeutic esophagogastroduodenoscopy (egd) with banding. Once the patient was removed from the procedure room, the physician observed bleeding around the band. The patient was sent to recovery for about a half an hour and the bleeding subsided on its own. No additional intervention was required. The patient was then discharged home. In addition, it was reported that during the procedure the physician experienced difficulty while inserting/ withdrawing the scope. It was reported that the physician believes that the smart band caused the scope to become stuck and resulted in the patient? S injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2951238-2018-00434 |
| MDR Report Key | 7716695 |
| Date Received | 2018-07-24 |
| Date of Report | 2018-09-18 |
| Date of Event | 2018-06-29 |
| Date Mfgr Received | 2018-09-12 |
| Date Added to Maude | 2018-07-24 |
| 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 | MS. CONNIE TUBERA |
| Manufacturer Street | 2400 RINGWOOD AVENUE |
| Manufacturer City | SAN JOSE CA 95131 |
| Manufacturer Country | US |
| Manufacturer Postal | 95131 |
| Manufacturer Phone | 4089355124 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SLK-6-LF SMART BAND LIGATION KIT |
| Generic Name | SMART BAND LIGATION KIT |
| Product Code | NLR |
| Date Received | 2018-07-24 |
| Catalog Number | SLK-6-LF |
| Lot Number | G11000136 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | INTELLIGENT ENDOSCOPY |
| Manufacturer Address | 4740 COMMERCIAL PARK COURT SUITE 1 CLEMMONS NC 27012 US 27012 |
| Brand Name | SLK-6-LF SMART BAND LIGATION KIT |
| Generic Name | SMART BAND LIGATION KIT |
| Product Code | MND |
| Date Received | 2018-07-24 |
| Catalog Number | SLK-6-LF |
| Lot Number | G11000136 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTELLIGENT ENDOSCOPY |
| Manufacturer Address | 4740 COMMERCIAL PARK COURT SUITE 1 CLEMMONS NC 27012 US 27012 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-07-24 |