MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,foreign report with the FDA on 2018-09-12 for JAW INS.ALLIGATOR FORCEPS 5MM 310MM PO615R manufactured by Aesculap Ag.
[119938740]
(b)(4). Batch history review: the lot/batch/serial number of the device was unknown, therefore a batch history review cannot be performed. Clinical investigation: although there was injury to user's finger, the expectation was the injured area would fully heal and most likely not negatively affect the surgeon in the future. Product investigation: the components of the complaint sample were examined visually and with a digital microscope. Visual inspection of the insulated outer (pm973r) tube revealed groves, scratches and visible damage. Visual inspection of the metal inner tube (pm600201) showed deformed tongs. Visual inspection of the shaft (b)(6) revealed that it was bent. Investigation was also conducted on the handle (b)(6) by dissembling the device from the monopolar handle ((b)(6)); creepage and unknown deposits were observed. According to the quality standard, a material defect and production error can be ruled-out. The following test was carried-insulation test at 2400 v, 10 ma and 30 seconds. A breakdown was noted. The creepage distance was caused by a build-up of tissue and body fluids from surgery. The visible damage, deformation and bent shaft were caused by improper handling due to mechanical overload. There was also a possibility of torsion or high leverage with the device. The scratches and the grooves at the outer insulated tube were most likely caused from damage encountered with other instruments or improper handling of the device. The outer tube showed heavy signs of wear. There was a possibility for disruptive discharges if the outer tube have scratches, grooves and fine cracks. The ifu cautions the user to, "keep the product's contact surface clean during surgery. Remove encrusted tissue residues or body fluids with a moistened swab. " root cause the root cause of this event was most likely attributed to usage-related. All related cases 400400560-9610612-2018-00400, 400400560-9610612-2018-00401.
Patient Sequence No: 1, Text Type: N, H10
[119938741]
It was reported that while the device was in use, the surgeon felt a slight electric shock through the rubber gloves. The electric shock caused burns on his finger.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00402 |
| MDR Report Key | 7868137 |
| Report Source | DISTRIBUTOR,FOREIGN |
| Date Received | 2018-09-12 |
| Date of Report | 2018-08-15 |
| Date Facility Aware | 2018-08-22 |
| Date Mfgr Received | 2018-08-15 |
| Date Added to Maude | 2018-09-12 |
| 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 | MRS NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP USA |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63042 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | JAW INS.ALLIGATOR FORCEPS 5MM 310MM |
| Generic Name | ADTEC MONOPOLAR |
| Product Code | KNF |
| Date Received | 2018-09-12 |
| Returned To Mfg | 2018-08-27 |
| Model Number | PO615R |
| Catalog Number | PO615R |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 4 YR |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-09-12 |