MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-04-28 for JARIT manufactured by Integra Lifesciences Corporation.
[43880721]
Patient Sequence No: 1, Text Type: N, H10
[43880722]
Surgeon placed grasper in through trocar to use on a laparoscopic cholecystectomy. When surgeon opened grasper to use the working side broke off and fell into abdomen. Piece retrieved, no injury to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5614283 |
| MDR Report Key | 5614283 |
| Date Received | 2016-04-28 |
| Date of Report | 2016-04-21 |
| Date of Event | 2016-03-30 |
| Report Date | 2016-04-21 |
| Date Reported to FDA | 2016-04-21 |
| Date Reported to Mfgr | 2016-04-21 |
| Date Added to Maude | 2016-04-28 |
| 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 |
| Brand Name | JARIT |
| Generic Name | RETRACTOR, SELF-RETAINING |
| Product Code | PKE |
| Date Received | 2016-04-28 |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION |
| Manufacturer Address | 4900 CHARLEMAR DRIVE BLDG A, CINCINNATI, OH 45227 US 45227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-04-28 |