MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-19 for 8383.73 manufactured by Richard Wolff.
[97751640]
Patient Sequence No: 1, Text Type: N, H10
[97751641]
When doctor went to use laparoscopic suction cannula ((b)(4)) the screw attachment on the stopcock part of the suction came off leaving the small spring in doctor's hand. The spring was caught by surgeon and did not reach the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7205578 |
| MDR Report Key | 7205578 |
| Date Received | 2018-01-19 |
| Date of Report | 2018-01-08 |
| Date of Event | 2018-01-04 |
| Report Date | 2018-01-08 |
| Date Reported to FDA | 2018-01-08 |
| Date Reported to Mfgr | 2018-01-08 |
| Date Added to Maude | 2018-01-19 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | COAGULATOR, LAPAROSCOPIC, UNIPOLAR (AND ACCESSORIES) |
| Product Code | HFG |
| Date Received | 2018-01-19 |
| Model Number | 8383.73 |
| Catalog Number | 8383.73 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 15 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RICHARD WOLFF |
| Manufacturer Address | 353 CORPORATE WOODS PKWY. VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-19 |