MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-02-19 for ABC HANDPIECE LAPAROSCOPIC 160656 manufactured by Consolidated Medical Equipment.
[136452819]
The report device is being returned to conmed for evaluation. A supplemental and final report will be filed following the completion of the device evaluation and complaint investigation. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[136452820]
The customer reported the 130344, single function abc handpiece, caught fire at the tip during a laparoscopic cholecystectomy on "(b)(6)" 2018. The fire was in the sterile field at the time, but it was stomped out by the surgeon. There were no patient or user injuries. The surgical team was familiar with the product due to continuous education by nursing staff. The abc handpiece was stored in the holster in the sterile field when not in use. The handpiece was attached to the 7550 argon generator. The handpiece was checked prior to surgery. It is unknown how long the handpiece was in use before it caught fire. This report is being raised based on device malfunction with potential for injury upon reoccurrence.
Patient Sequence No: 1, Text Type: D, B5
[140022283]
Correction: previously stated catalog # 130344, lot # 201810294 corrected to catalog # 160656, no lot # provided. Previously stated k871435 corrected to k925903. Two (b)(4) were received, one in opened unoriginal packaging the other in opened original packaging, the reported catalog number was verified, the lot number was not verified. Visual inspection found that the device that did not have original packaging appeared burnt at the distal end and that the shaft and coating were damaged. The device was also functionally inspected with a system 7500 esu ((b)(4)). Functional inspection found that the argon beam ejected straight from the tip and did not appear to arc or creep along the sides. No smoke, fire, or sparking was observed during testing. The manufacturing documents from the device history record could not be reviewed due to no lot number being provided. A two-year review of complaint history revealed there has been 1 complaint regarding 2 devices for this device family and failure mode. During the same time frame, (b)(4) devices have been manufactured and shipped worldwide. Should all the complaint devices have been found confirmed, the rate of failure would be (b)(4). Per the instructions for use, the user is advised the following; not to use in the presence of flammable anesthetics, disinfecting agents, oxygen-rich environments or other combustible materials. Before use, inspect the cord insulation and hand piece integrity and condition. If damaged, chipped, cut, or nicked, do not use the hand piece /probe. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[140036036]
Correction: previously stated the date of incident was (b)(6) 2018, the date of incident is actually (b)(6) 2019. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
[140332905]
Correction: previously stated the date of incident was (b)(6) 2019, the date of incident is actually (b)(6) 2018. This issue will continue to be monitored through the complaint system to assure patient safety.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3007305485-2019-00033 |
| MDR Report Key | 8349414 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-02-19 |
| Date of Report | 2019-03-27 |
| Date of Event | 2018-12-19 |
| Date Mfgr Received | 2019-03-19 |
| Device Manufacturer Date | 2018-10-29 |
| Date Added to Maude | 2019-02-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MELANIE HANSEN |
| Manufacturer Street | 11311 CONCEPT BOULEVARD |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995209 |
| Manufacturer G1 | CONSOLIDATED MEDICAL EQUIPMENT |
| Manufacturer Street | ALEJANDRO DUMAS AVE, 11321 COMPLEJO INDUSTRIAL CHIHUAHUA |
| Manufacturer City | CHIHUAHUA 31136 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 31136 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABC HANDPIECE LAPAROSCOPIC |
| Generic Name | ARGON HANDPIECE |
| Product Code | HAM |
| Date Received | 2019-02-19 |
| Returned To Mfg | 2019-02-19 |
| Catalog Number | 160656 |
| Lot Number | 201810294 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONSOLIDATED MEDICAL EQUIPMENT |
| Manufacturer Address | ALEJANDRO DUMAS AVE, 11321 COMPLEJO INDUSTRIAL CHIHUAHUA CHIHUAHUA 31136 MX 31136 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-02-19 |