MAUDE Adverse Event Report: AESCULAP AG POTTS-DEMARTEL SCISSORS 60DG 220MM; CARDIO-THORACIC SURGERY

Model Number BC650R

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/22/2019

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

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).

• Brand Name: POTTS-DEMARTEL SCISSORS 60DG 220MM
• Type of Device: CARDIO-THORACIC SURGERY
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: kerstin rothweiler ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9628358
• MDR Text Key: 176387392
• Report Number: 9610612-2019-00928
• Device Sequence Number: 1
• Product Code: LRW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BC650R
• Device Catalogue Number: BC650R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention