MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-06-03 for TEBBETTS FIBEROPTIC SS RETR 15CMX30MM 88-1188 manufactured by Carefusion.
[4614282]
Burn on (b)(6) 2014. A? Medwatch report #(b)(4) was received. The postmark date was (b)(4) 2014. The report states "surgeon requested lighted retractor during the surgery. Physician performing subsequent reconstruction surgery noticed a blister on patient's right chest that may be a burn. Ordered silvadene cream postop. " the procedure was a left mastectomy. The report also stated that on (b)(6) 2014, a replacement retractor was received. New retractor and light cord do not get warm at the retractor/light cord connection even when running for extended periods of time on the highest setting. The old one gets hot very quickly. Clinical engineering recommendations: 1) do not have 3rd party vendors repair light cords: send them to their original manufacturer. 2) do not use the "old retractor" and old light cord that burned the patient" on (b)(4) 2014. A message was left for the reporter who is in risk management at the facility. Awaiting a response.
Patient Sequence No: 1, Text Type: D, B5
[12014107]
The device was not received for evaluation. If it becomes available, a follow-up emdr will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1038548-2014-00040 |
| MDR Report Key | 3846118 |
| Report Source | 05 |
| Date Received | 2014-06-03 |
| Date of Report | 2014-06-03 |
| Date of Event | 2014-02-13 |
| Date Mfgr Received | 2014-05-08 |
| Date Added to Maude | 2014-06-03 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | JILL RITTORNO |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8473628056 |
| Manufacturer G1 | CAREFUSION 2200, INC. SNOWDEN PENCER PRODUCTS |
| Manufacturer Street | 5175 SOUTH ROYAL ATLANTA DR |
| Manufacturer City | TUCKER 30084 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30084 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TEBBETTS FIBEROPTIC SS RETR 15CMX30MM |
| Generic Name | RETRACTOR, FIBEROPTIC |
| Product Code | FDG |
| Date Received | 2014-06-03 |
| Model Number | 88-1188 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-06-03 |