MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2017-07-03 for MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE SRS05 MMAA1006004 manufactured by Medigus Ltd.
[79025856]
(b)(4) was used as a patient code because there were no codes that fit the diagnosis of pneumoperitoneum.
Patient Sequence No: 1, Text Type: N, H10
[79025857]
After muse surgery on (b)(6) 2017, the patient began to experience discomfort. Test results indicated that he had developed a pneumoperitoneum. He was given gastrointestinal decompression treatment, rehydration and medications to reduce pain and prevent infection. The patient's hospital stay was prolonged due to the pneumoperitoneum. The patient was released from the hospital on (b)(6) 2017.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004444684-2017-00002 |
| MDR Report Key | 6684898 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2017-07-03 |
| Date of Report | 2017-06-07 |
| Date of Event | 2017-06-07 |
| Date Mfgr Received | 2017-06-07 |
| Device Manufacturer Date | 2016-02-06 |
| Date Added to Maude | 2017-07-03 |
| 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 RONEN COHEN |
| Manufacturer Street | 7A INDUSTRIAL PARK POB 3030 |
| Manufacturer City | OMER, ISRAEL 84965 |
| Manufacturer Country | IS |
| Manufacturer Postal | 84965 |
| Manufacturer G1 | MEDIGUS LTD |
| Manufacturer Street | 7A INDUSTRIAL PARK POB 3030 |
| Manufacturer City | OMER, ISRAEL 84965 |
| Manufacturer Country | IS |
| Manufacturer Postal Code | 84965 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDIGUS ULTRASONIC SURGICAL ENDOSTAPLER SYSTEM MUSE |
| Generic Name | ENDOSCOPE |
| Product Code | ODE |
| Date Received | 2017-07-03 |
| Model Number | SRS05 |
| Catalog Number | MMAA1006004 |
| Device Expiration Date | 2018-02-28 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIGUS LTD |
| Manufacturer Address | 7A INDUSTRIAL PARK POB 3030 OMER, ISRAEL 84965 IS 84965 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2017-07-03 |