MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,other report with the FDA on 2018-12-07 for SUSI METZENBAUM SCISSORS CVD.180MM BC606SU manufactured by Aesculap Ag.
[129614138]
(b)(4). Investigation: the reported device was returned for investigation, the broken piece was not returned. Visual inspection of the device indicated it was disinfected with helipur, which caused the surface of the instrument to turn green. The reported breakage of the device was confirmed. Microscopic inspection of the breakage surface indicated no pores or inclusions (foreign bodies). The device quality and manufacturing records were reviewed for the lot number of the susi thorax drainage set basic (reference number 5062010-b; lot number 18e26844) and were found to be according to specification valid at the time of production. Review of complaint history indicates not other reports filed for this batch number. It was reported that the scissors were used to "spreading the intercostal space"; according to the intended purpose of this device, this type of scissor must be used for cutting, preparation of tissue, organs and other medical "auziliary" materials. Based on review of device history records, complaint data and reported use of the device, the breakage of the scissors may be attributed to improper handling that resulted in a forced fracture due to mechanical overload. "corrrective"/preventive action is not required.
Patient Sequence No: 1, Text Type: N, H10
[129614139]
It was reported that during emergency admission the patient was experiencing a complete pneumothorax on the left (this was the third occurrence for this patient). An emergency oral clarification, using thoracic suction drainage (tsd) system was conducted under local "anesthsia" and sterile cautery. The intercostal space was spread with scissors and one branch of the scissors broke off. The broken piece remained in the intrathoracic area of the left lung. The tsd was then properly inserted and the patient was placed in the intensive care unit where intravenous antibiotics were started ("tazobac"). X-ray indicated a regular positioning of the tsd and complete regredient pneumothorax as well as a foreign body in the left basal intrathoracic area. Video assisted thoracoscopic surgery (vats) was performed to remove the foreign body from the patients left hemithorax on (b)(6) 2018. Patient status is unknown at the time of this report. Reported device is part of thorax drainage kit (reference number 5062010-b / batch number: 18e26844) - reported as concomitant device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2018-00558 |
| MDR Report Key | 8142084 |
| Report Source | FOREIGN,OTHER |
| Date Received | 2018-12-07 |
| Date of Report | 2018-12-07 |
| Date of Event | 2018-11-15 |
| Date Facility Aware | 2018-11-26 |
| Date Mfgr Received | 2018-11-15 |
| Date Added to Maude | 2018-12-07 |
| 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 | MS. 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 AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUSI METZENBAUM SCISSORS CVD.180MM |
| Generic Name | SCISSORS |
| Product Code | LRW |
| Date Received | 2018-12-07 |
| Returned To Mfg | 2018-11-29 |
| Model Number | BC606SU |
| Catalog Number | BC606SU |
| Device Availability | R |
| 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. Required No Informationntervention | 2018-12-07 |