MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2016-03-09 for MUSE-MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM SRS05 MMAA10060000 manufactured by Medigus Ltd..
[39978199]
Device performed as intended. No malfunction or detect of device noted. (b)(4). Anatomy related issue, not device.
Patient Sequence No: 1, Text Type: N, H10
[39978200]
At the time of discharge, the patient noticed she could not properly close her jaw and later complained of jaw pain. Conservative management recommended. Jaw occlusion/pain improved, but was not completely resolved upon 30-day telephone follow-up. Subject was found not to be compliant with her therapeutic program. Manufacturer notified due to persistence of jaw issue. Physician attributed event to the patient's anatomy (esophagus/upper gi tract was a tight fit around device). Patient continues on conservative management.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004444684-2016-00001 |
| MDR Report Key | 5489220 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2016-03-09 |
| Date of Report | 2016-02-19 |
| Date of Event | 2016-01-12 |
| Date Facility Aware | 2016-02-29 |
| Date Mfgr Received | 2016-02-19 |
| Device Manufacturer Date | 2015-08-10 |
| Date Added to Maude | 2016-03-09 |
| 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 Street | 7A INDUSTRIAL PARK P.O. BOX 3030 |
| Manufacturer City | OMER, ISRAEL 84965 |
| Manufacturer Country | IS |
| Manufacturer Postal | 84965 |
| Manufacturer Phone | 86466880 |
| Manufacturer G1 | MEDIGUS, LTD. |
| Manufacturer Street | SUITE 7A INDUSTRIAL PART P.O. BOX 3030 |
| Manufacturer City | OMER, ISRAEL 84965 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 84965 |
| Single Use | 3 |
| Remedial Action | PM |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MUSE-MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM |
| Generic Name | ENDOSTAPLER, PRODUCT CODE: ODE |
| Product Code | ODE |
| Date Received | 2016-03-09 |
| Model Number | SRS05 |
| Catalog Number | MMAA10060000 |
| Lot Number | 23400 |
| Device Expiration Date | 2016-09-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 MO |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIGUS LTD. |
| Manufacturer Address | SUITE 7A INDUSTRIAL PARK P.O. BOX 3030 OMER, ISRAEL 84965 IS 84965 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Deathisabilit | 2016-03-09 |