MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-21 for S-L RETRACTOR TRANS MULTI-L 150MM RACK S-0103 manufactured by Carefusion, Inc.
[78249855]
(b)(4). Should any additional information be obtained for this issue a follow up emdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
[78249856]
The customer reported, during surgery the doctor was getting ready to use the device and realized that the product was not staying locked. Immediately stopped using and was able to use other one on hand. The key portion that helps it move in and out that makes it adjustable does not stay in place, making it fall in and out. The key that ratchets the retractor has a small screw directly in the end of it. That screw came out while opening the retractor on several cases. It went onto the field and had to be retrieved. No patient harm. No patient or user harm and no medical intervention required. Update 21jun2017 after multiple attempts, no additional information was received from the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1923569-2017-00048 |
| MDR Report Key | 6657422 |
| Date Received | 2017-06-21 |
| Date of Report | 2017-06-27 |
| Date of Event | 2017-05-24 |
| Date Mfgr Received | 2017-06-21 |
| Date Added to Maude | 2017-06-21 |
| 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 | ANNA WEHRHEIM |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 5 SUNNEN DR |
| Manufacturer City | ST. LOUIS MO 63143 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63143 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | S-L RETRACTOR TRANS MULTI-L 150MM RACK |
| Generic Name | RETRACTOR, SELF-RETAINING, FOR NEUROSURGERY |
| Product Code | GZT |
| Date Received | 2017-06-21 |
| Model Number | S-0103 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-21 |