MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-08-29 for MDS1344350EY manufactured by Medline Industries Inc..
[118719460]
It was reported that, while undergoing a strabismus surgery, bilateral lateral rectus recession, the forceps holding onto the tissue popped open and fell to the floor. The forceps that fell were no used again throughout the procedure; however the event did result in a delay in the procedure that required additional anesthesia to be administered. The patient made a full recovery with no further incident reported. There was no report of any adverse patient consequence and no effect on the patient's stability, as a result of the incident. The sample was returned for evaluation and the customer reported issue was not confirmed. Due to the reported incident and subsequent need for additional anesthesia this medwatch is being filed. If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[118719461]
Locking forceps would not hold onto tissue resulting in forceps popping off in the middle of a procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1417592-2018-00083 |
| MDR Report Key | 7829401 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-08-29 |
| Date of Report | 2018-08-29 |
| Date of Event | 2018-07-12 |
| Date Mfgr Received | 2018-07-31 |
| Date Added to Maude | 2018-08-29 |
| 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 | KAREN TRUTSCH |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD IL 60093 |
| Manufacturer Country | US |
| Manufacturer Postal | 60093 |
| Manufacturer Phone | 8476434960 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | SURGICAL EYE TRAY |
| Product Code | PZG |
| Date Received | 2018-08-29 |
| Returned To Mfg | 2018-08-27 |
| Catalog Number | MDS1344350EY |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE INDUSTRIES INC. |
| Manufacturer Address | THREE LAKES DRIVE NORTHFIELD IL 60093 US 60093 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-08-29 |