MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2019-01-07 for SCISSORS, 5 FR., SEMIFLEXIBLE A4826 manufactured by Olympus Winter & Ibe Gmbh.
[132204321]
The suspect medical device has not yet been returned to olympus for evaluation/investigation. Therefore, the exact cause of the patient? S outcome and the reported phenomenon could not be determined and is being judged as unknown. However, if the suspect medical device is returned for evaluation/investigation or additional significant information becomes available, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[132204322]
Olympus was informed that during a therapeutic laparoscopic cholecystectomy procedure at an unknown date, the patient sustained a perforation of the bowel. The intended procedure was converted to open surgery where the perforation was treated. The patient was subsequently hospitalized for recovery for three days.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610773-2019-00040 |
| MDR Report Key | 8221492 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2019-01-07 |
| Date of Report | 2019-01-07 |
| Date Mfgr Received | 2018-12-28 |
| Date Added to Maude | 2019-01-07 |
| 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. DANIEL WLADOW |
| Manufacturer Street | KUEHNSTRASSE 61 |
| Manufacturer City | HAMBURG 22045 |
| Manufacturer Country | GM |
| Manufacturer Postal | 22045 |
| Manufacturer Phone | 4940669662 |
| Manufacturer G1 | DAUSCH MEDIZINTECHNIK GMBH |
| Manufacturer Street | DAIMLERSTRASSE 13 |
| Manufacturer City | WURMLINGEN 78573 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78573 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCISSORS, 5 FR., SEMIFLEXIBLE |
| Generic Name | HAND INSTRUMENTS, STANDARD (WITHOUT CURRENT) |
| Product Code | LRW |
| Date Received | 2019-01-07 |
| Model Number | A4826 |
| Catalog Number | A4826 |
| Lot Number | 814806 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OLYMPUS WINTER & IBE GMBH |
| Manufacturer Address | KUEHNSTRASSE 61 HAMBURG 22045 GM 22045 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2019-01-07 |