MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-01-24 for POTTS-DEMARTEL SCISSORS 60DG 220MM BC650R manufactured by Aesculap Ag.
[176387392]
Manufacturing side evaluation: we received a complaint about one bc650r potts-demartel scissors 60dg 220mm. We received a complaint about one bc650r potts-demartel scissors 60dg 220mm. Consequences for the patient: intra-operative medical intervention was necessary x-ray. Investigation: the instrument arrived in a clean status but without the broken off part and without the screw. The investigation was carried out visually and microscopically with the digital microscope vhx-5000 keyence (eq. -nr. (b)(4)) and the digital-camera "panasonic dmc tz8". We made a visual inspection of the instrument. Here we found the labeling bc 650. This is an indicate for a manufacturing date before 1986. Additionally we detected visible damaged cutting edges. Furthermore we discovered processing marks, grinding marks, dark and golden discoloration. We also made an optical inspection of the fracture surface. Here we found the crack origin, crack outlet, dark and golden discoloration. The grain size shows no abnormalities. Additionally the instrument was sent to the laboratory management for further analysis. The report will be updated after the investigation of the laboratory management. Batch history review: the traceability of articles without batch management requirement is guaranteed by the production order number, which can be traced over the production period and the corresponding customer (backtrack). In addition, the raw materials, semi-finished parts, etc. Used for the order are documented in the manufacturing history records (dhr - device history records). This ensures the traceability of the internal supply and production chain. Internal traceability is thus guaranteed. Conclusion and root cause: the root cause of the problem is most probably maintenance related. Rationale: investigations lead to the assumption that the breakage was caused by stress-corrosion cracking. According the dark discoloration, it appears that the crack outlet could have been seen at the outside edge of the instrument. It also appears that the dark discoloration are signs of an old crack. The visible damaged cutting edges and grinding marks could have caused by a mechanical overload situation. It appears that the visible damaged cutting edges were caused by an improper handling due to cutting of a too hard material or something like else. The grinding marks could caused by high leverage with the instrument. This two causes led to an insufficient cutting. If the instrument cuts very bad or not at all in addition with a mechanical overload situation these may be fracture-triggering or a pre-damage. Due to the existing pre-damage or weak point, the reprocessing was fracture-triggering. The dark discolorations around the hinge area could case due to insufficient lubrication and / or foreign bodies. This could lead to corrosion of the metallic friction surfaces that move relative to each other (especially in locks / joints and sliding paths). The dark discoloration around the hinge area could also be pitting. The following points could be the cause of this: exposure due to halide ions (bromides, iodides and chlorides) but especially chlorides that locally break through the passive layer of instrument steel thus causing pitting. Dried-on organic residues, e. G. Blood, pus, secretions, frequent pitting is due to the use of liquids with high chloride content or more specifically due to dry residues of such liquids adhering to the instrument surfaces, e. G. If the concentration of chlorides in the final rinse water is too high or if residues of physiological salt solutions remain on the instruments. Brand new instruments are particularly susceptible to attack by media containing chlorides due to their still thin passive layer. Instruments that have been use for some time are more resistant to chloride attack because they have developed a thicker passive layer.
Patient Sequence No: 1, Text Type: N, H10
[176387393]
It was reported that there was an issue with potts-demartel scissors. The following information was reported: the tip was broken during the procedure, without significant force. All the parts were removed according to the surgeon, and this was confirmed via x-ray results. The breakage had occurred at the level of the screw, and into several pieces. Another instrument was available for the surgery. An additional medical intervention was necessary. Additional information was not provided nor available. The malfunction is filed under (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610612-2019-00928 |
| MDR Report Key | 9628358 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-24 |
| Date of Event | 2019-12-22 |
| Date Mfgr Received | 2019-12-26 |
| Date Added to Maude | 2020-01-24 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS KERSTIN ROTHWEILER |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78501 |
| 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 | POTTS-DEMARTEL SCISSORS 60DG 220MM |
| Generic Name | CARDIO-THORACIC SURGERY |
| Product Code | LRW |
| Date Received | 2020-01-24 |
| Returned To Mfg | 2020-01-13 |
| Model Number | BC650R |
| Catalog Number | BC650R |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-01-24 |