MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2013-11-22 for TEBBETTS FIBEROPTIC SS RETR 15CMX30MM 88-1088 manufactured by Carefusion.
[4080344]
Burn. The? Instrument is getting very hot and causing burns where the cord meets the instrument and where instrument has suction. Additional information received from the customer (b)(6) 2013: it was reported that the retractor was placed on the patients abdomen and the patient suffered a burn on the abdomen that was tended to with ointment (name unknown). The procedure (type unknown) was completed as planned. Per the customer, two types of light sources were used but it is unclear which was used in each case. The light sources were "bfw" and "pillings". The customer had no further information on the light sources. This complaint is associated with (b)(4): additional information received from the customer (b)(6) 2013. It was reported that we will not be receiving the instruments for evaluation as they are still in use. The customer stated that they had used a 3. 5 mm light cable.
Patient Sequence No: 1, Text Type: D, B5
[11360993]
(b)(4) - the device was not received for evaluation. If the instrument becomes available, and follow-up mdr will be sent.
Patient Sequence No: 1, Text Type: N, H10
[11430116]
(b)(4). This complaint is associated with (b)(4). It was reported that the instrument was getting hot and causing burns where the cord meets the instrument and where the cord has suction. Additional information was received from the customer on (b)(6) 2013. It was reported that the retractor was placed on the patient? S abdomen and the patient suffered a burn on the abdomen that was tended to with ointment (type unknown). The type of procedure was unknown but was completed as planned. Per the customer, two types of light sources were used but it is unclear which was used in each case. The light sources were? Bfw? And? Pillings?. On 11/12/2013, the customer notified customer advocacy that the instruments would not be sent in for evaluation on december 17th 2013, a customer visit was conducted by customer advocacy who met with the facilities operating room (or) coordinator and the nurse manager. The operating room coordinator provided the device 88-1088 that he stated was used in both complaints listed. Therefore a (b)(4) will reflect the change in the submission. Prior to this visit, the customer had stated that the cord used was a 3. 5mm when in fact, it was a 5mm cord which is the incorrect size to use for this product. The light source was not brought for evaluation. The device 88-1088 had a lot code of a980521 which was confirmed by our manufacturing facility to have been manufactured in 1998. The device potentially has been in use for 15 years. The customer stated that the retractor had been taken out of circulation for use in the operating room. He did remark that the staff is aware of the issue and do try to wrap the instrument in a wet lap and / or turn off the light source when not in use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1038548-2013-00030 |
| MDR Report Key | 3483609 |
| Report Source | 04,05 |
| Date Received | 2013-11-22 |
| Date of Report | 2013-10-30 |
| Date of Event | 2013-10-30 |
| Date Mfgr Received | 2013-10-30 |
| Date Added to Maude | 2013-11-25 |
| 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 | 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 | 2013-11-22 |
| Model Number | 88-1088 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2013-11-22 |