MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2012-10-17 for TUBE CEV649-5B DIA 5MM 350MM manufactured by Xomed Microfrance Mfg.
[15427894]
It was reported that during a laparoscopic surgical procedure, the surgeon received a burn to thumb during coagulation. (the instrument has not been identified - potentially this manufacturer but the instrument could not be identified or verified). The surgeon stated there was not a significant injury, very local, and the burn should heal with no intervention. The surgeon reported they had received low quality of surgical gloves, which he suspects could be the cause.
Patient Sequence No: 1, Text Type: D, B5
[15690007]
(b)(6). (b)(4). Analysis: tube (b)(4) dia 5mm 350mm: the sheath has probably been damaged by some shocks and an excessive abrasion. Handle (b)(4) dia 5mm str monopolar: no problem noted. The instrument is conforms to manufacturing standard. Scissors insert (b)(4) 350mm dia 5mm: the instrument has probably repaired by an external provider not approved by microfrance (etching from another source noted). Event results: no factory defects have been detected on the microfrance instruments returned. The investigation has highlighted a repair outside of medtronic and a damaged sheath. Although we do not recommend such practices, these anomalies, from our point of view, would not likely lead to the reported event. Considering the explanations from the surgeon, it is probable that the burn is the consequence of the electric arc following a damaged glove. (quality of gloves used recently was reported to be bad). This is the first reported occurrence of this type of incident on this instrument in the past 12 months. The instrument used could not be identified but is being presumed a potentially microfrance (mxi) instrument, but with no certainty. Discussion with the surgeon revealed the surgeon noted a bad quality of gloves was being used. From this discussion, the most likely root cause for this incident is an electric arc being allowed to contact the surgeon due to wearing a damaged glove. (b)(4) concurs that the most likely root cause is the wearing of poor gloves during the procedure and the incident is not due to the instruments used in the procedure. Mxi reports that there is no risk of death or permanent injury. No further investigations or actions are necessary. Product description: cauterization instruments is intended for use during laparoscopic surgical procedure to coagulate tissue or arrest bleeding using a high frequency electric current.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9680837-2012-00021 |
| MDR Report Key | 2795086 |
| Report Source | 01,05,06,07 |
| Date Received | 2012-10-17 |
| Date of Report | 2012-09-17 |
| Date of Event | 2012-08-01 |
| Date Mfgr Received | 2012-09-17 |
| Date Added to Maude | 2013-01-30 |
| 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 | RN RAHN GREENE |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328197 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TUBE CEV649-5B DIA 5MM 350MM |
| Generic Name | ELECTROCAUTERY, ENDOSCOPIC AND ACCESSORIES |
| Product Code | HIM |
| Date Received | 2012-10-17 |
| Returned To Mfg | 2012-09-11 |
| Model Number | CEV649-5B |
| Catalog Number | CEV649-5B |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOMED MICROFRANCE MFG |
| Manufacturer Address | SAINT-AUBIN-LE-MONIAL BOURBON-L'ARCHAMBAULT 3160 FR 3160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-17 |